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18 Job openings at Precision Value & Health
Scientific Data Analyst

Bangalore Urban, Karnataka, India

0 years

Not disclosed

On-site

Full Time

Scientific Data Analyst - Clinical Trial Services Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5592 Job Description Position Summary : Requirements The Scientific Data Analyst will be responsible for developing and maintaining Tableau dashboards and SQL programming to support clinical data management and analysis. This role requires a strong technical background, a good understanding of various clinical trial domains, and expertise in data management, including discrepancy management. The successful candidate will develop the dashboard based on the requirements to ensure accurate and efficient data handling for clinical studies. Essential functions of the job include but are not limited to: Essential functions of the job include but are not limited to Data Analysis and Interpretation: Analyze and interpret complex scientific data from various sources to identify trends, patterns, and insights. Database Management: Develop, maintain, and optimize SQL databases to manage and retrieve data efficiently. Data Visualization: Create and present data visualizations using tools such as Tableau, Power BI, or similar, to communicate findings to stakeholders clearly and effectively. Collaboration: Work closely with clinical team and other stakeholders to support data-driven decision-making processes. Compliance and Data Integrity: Ensure data integrity and compliance with regulatory standards and best practices in data management. Technical Expertise: Provide technical expertise in data analysis, visualization tools, and methodologies to support various projects. Qualifications Minimum Required: 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline. 3-years proven experience in a similar role, preferably in a clinical or healthcare setting. Proficiency in Tableau and Excel for data visualization. Strong knowledge of SQL for database management and programming. Good understanding of various clinical trial domains and data management principles. Excellent analytical and problem-solving abilities. Strong verbal and written communication skills to effectively collaborate with clinical teams and stakeholders. High level of attention to detail and commitment to data accuracy. Other Required Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint) Preferred Experience with other data visualization tools (e.g., Power BI). Familiarity with clinical trial data and regulatory requirements. Certification in data management or related fields. Skills Demonstrates solid interpersonal skills. Demonstrates, or can be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. Competencies Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders. Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Senior Clinical Data Associate

Bengaluru

1 - 5 years

INR 3.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Senior Clinical Data Associate - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5546 Position Summary The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed This position may perform database development and testing, as well as additional data management activities, Essential functions of the job include but are not limited to Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May provide input into timelines Ensure that clinical data management deadlines are met with quality May assess resource needs for assigned projects, as needed, Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation May oversee overall quality of the clinical database, Assist in specifying requirements for all edit check types e-g , electronic, manual data review, edit checks, etc Responsible for creating, revising, appropriate versioning and maintaining data management documentation, Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed, Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Assist with coordinating SAE/AE reconciliation Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: 5+ yearsexperience Bachelors and/or a combination of related experience Other Required Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, Able to handle a variety of clinical research tasks, Excellent organizational and communication skills Professional use of the English language; both written and oral, Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred Experience in a clinical, scientific or healthcare discipline, Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc ?) Oncology and/or Orphan Drug therapeutic experience Skills Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes Competencies Motivates project team members to meet timelines and project goals Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Resolves project related problems and prioritizes workload to meet deadlines with minimal support Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers We want to emphasize that these offers are not associated with our company and may be fraudulent in nature Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process, Apply Now

Clinical Data Associate II

Bengaluru

1 - 4 years

INR 3.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Clinical Data Associate II - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5545 Position Summary The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed This position may perform database development and testing, as well as additional data management activities, Essential functions of the job include but are not limited to Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation Assist in specifying requirements for all edit check types e-g electronic, manual data review, edit checks, etc Responsible for creating, revising, appropriate versioning and maintaining data management documentation, Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Assist with coordinating SAE/AE reconciliation Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 2+ yearsexperience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Preferred Experience in a clinical, scientific or healthcare discipline It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers We want to emphasize that these offers are not associated with our company and may be fraudulent in nature Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process, Apply Now

Operations Specialist I

Bangalore Urban, Karnataka, India

1 - 2 years

Not disclosed

On-site

Full Time

Operations Specialist I - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5653 Position Summary The Operations Specialist I supports a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area in which the Operations Specialist is aligned, including Resource & Contractor Management, Vendor Management, and Operational Excellence. The Operations Specialist I supports the execution of the functional priorities by supporting leadership in execution of a wide range of tasks and activities. Essential functions of the job include but are not limited to the following as needed: Support in the development of documentation to support processes, procedures, roles and responsibilities Prepare tools and templates as needed to ensure proper execution of processes and procedures Support management of a wide range of materials, ensure tools, templates, process documents are up to date Support communication of new processes to stakeholders Assist in planning, organizing and coordinating specific initiatives Schedule meetings, taking notes, identifying next steps across a range of stakeholders Assist with management of data, spreadsheets, trackers, etc. as needed Help with the onboarding of new contractors, staff, or others as appropriate May travel including overnight travel as needed Qualifications Minimum Required: BA degree or equivalent regional degree or equivalent combination of education and experience 1-2 years experience with operational support, process improvement or related function Other Required Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). Ability to communicate both written and verbal in English with demonstrated proficiency (Business Professional level) Competencies Demonstrates, or able to learn and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. Demonstrates solid interpersonal skills. Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders. Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Medical Coder

Chennai, Tamil Nadu, India

4 years

Not disclosed

On-site

Full Time

Medical Coder - Location: Chennai Tamil Nadu India Chennai Tamil Nadu India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5651 Precision for Medicine is seeking a talented Medical Coder to provide comprehensive Coding and related data management support throughout all phases of the clinical trial data management process. With direct supervision work with a team of medical coders, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data coding and quality review within a dynamic team environment . Position Summary The Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner Essential functions of the job include but are not limited to Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness,and that tasks are performed in a timely manner Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 4+ years’ experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required 2+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

IT Business Analyst Manager (Business Intelligence)

Itanagar, Arunachal Pradesh, India

8 years

Not disclosed

Remote

Full Time

IT Business Analyst Manager (Business Intelligence) - Location: Remote Remote India Remote Remote India Job Type: regular full-time Division: Precision for Medicine Business Unit: QuartzBio Requisition Number: 5657 QuartzBio (www.quartzbio.com) is the Precision Medicine Intelligence Company. Our first-in-class Precision Medicine AI Agent Platform enables autonomous data ingestion and conversational insights across the precision medicine value chain. Powered by a network of domain-specific AI agents, our solutions amplify the efforts of operations, translational, informatics, and IT teams, using AI-driven integration of biomarker, sample, and clinical data to create a unified, scalable data ecosystem. R&D teams can shorten time from data to insights, analytics, and visualizations, accelerating study close and time-to-market. Transform the way precision medicine teams work with 360° intelligence. Position Summary We are seeking a Business Analyst Manager(Business Intelligence), to guide our strategic decision-making through advanced business intelligence, data analysis, and cross-functional collaboration. This role requires an experienced analyst who is adept at working across teams to identify key Business intelligence product scope opportunities, performs analysis and solution detailing to drive the development of scalable Business intelligence solutions in sample life cycle management and Biomarker data analysis. The ideal candidate brings deep analytical expertise, hands on data analysis skills, a strong understanding of Business intelligence technologies, and the ability to convert ideas to product requirements. You will lead complex analytics initiatives, analyses stakeholder business intelligence requirements, and help enable PDLC (Product development life cycle) process in the analytics workstream. Key Responsibilities Product Strategy & Feature Management Manage the intake and prioritization of business intelligence product requests. Decompose product requirements into features, and translate them into detailed epics and user stories. Collaborate with product leads to define release scopes and develop product roadmaps. Define and manage business and technical requirements for core BI components and data pipeline initiatives. Technical Analysis & Integration Conduct backend data pipeline analysis to enrich and validate feature requests. Translate complex or ambiguous problems into structured analyses and communicate insights to both technical and non-technical stakeholders. Work closely with AI and intelligent agent teams to integrate BI capabilities with virtual assistants and intelligent systems. Cross-Functional Collaboration Lead product grooming sessions with stakeholders to align on product deliverables. Collaborate with the design team to create user journey maps, wireframes, and other UX deliverables. Partner with engineering teams during sprint demos to review progress and provide product feedback. Define and implement QA processes in collaboration with the QA team to ensure high product quality. Adoption, Enablement & Innovation Drive adoption of business intelligence and semantic layers to empower business users with self-service analytics. Own the full project lifecycle—from scoping and stakeholder alignment to delivery, documentation, and user enablement. Identify opportunities to leverage generative AI to automate insights, enhance reporting, and improve user experience. Continuous Improvement Stay current with BI and analytics trends, tools, and best practices in SaaS environments. Continuously enhance technical skills and remain informed about emerging technologies in the BI space. Qualifications Bachelor’s degree related field and a minimum of 8 years of relevant work experience in Business and technical analysis tasks related to Business intelligence. 5+ years of experience in Business Analysis, Analytics, or BI roles with increasing levels of responsibility. 4-6 years of experience working in a customer-facing role and leading projects. Advanced proficiency in SQL/MySQL, data visualization tools (e.g., Tableau, Power BI, Looker) , and data modeling concepts. Familiarity with GenAI tools and frameworks (e.g., LangChain, OpenAI, Hugging Face) is a plus. Experience working with modern data stacks (e.g., Snowflake, dbt, Airflow, Redshift, databricks). Experience in clinical operations and Biomarker data analytics (preferred) Excellent problem-solving skills, analytical skills and ability to manage ambiguity with minimal oversight. Excellent communication skills – can tailor messaging to executive, technical, and non-technical audiences. Experience with Agile methodologies and project management tools such as Jira, Confluence, and Asana. Proven leadership in managing complex projects or functional areas, with the ability to balance short-term deliverables and long-term strategic goals. Demonstrated success in leading cross-functional initiatives and mentoring team members. Strong project management skills, including scheduling, budgeting, and status reporting, with a solid understanding of project management processes and tools. Strong written and verbal communication skills. Ability to write complex reports in a clear and concise manner. Provide expertise and guidance to team members. Actively contributes to the development of departmental strategies. Continuously improve technical skills and stay up to date with emerging technologies. Meets budgets and schedules for the entire project lifecycle. Other duties as assigned. Leadership Expectations Follows Company's Principles and code of ethics on a day-to-day basis. Shows appreciation for individual talents, differences, and abilities of fellow team members. Listen and responds with appropriate actions. Supports change initiatives and continuous process improvements. Communicates effectively and appropriately with colleagues, supervisors and clients. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Data Analyst

Pune, Maharashtra, India

0 - 2 years

Not disclosed

On-site

Full Time

Data Analyst - Location: Pune Maharashtra India Pune Maharashtra India Job Type: Regular Full-time Division: Precision AQ Business Unit: Precision AQ Corporate Requisition Number: 5671 Job Summary: We are seeking a detail-oriented Data Analyst to join our team in India. This hybrid role involves managing time transfers of billable employee hours between projects, ensuring accurate data entry and timely updates. The specialist will also handle the integration of time data from various business groups into our ERP system. Key Responsibilities Time Transfers: Process time transfers of billable employee hours between projects once approved by project managers. Data Integration: Upload time data from business groups not in our ERP system into the ERP system to ensure accurate booking against projects. Data Accuracy: Ensure all data entered is accurate and up to date, maintaining high standards of data integrity. Reporting: Generate and distribute reports related to time entries and transfers as required. Communication: Collaborate with project managers and business groups to resolve any discrepancies or issues related to time entries. Documentation: Maintain detailed records of all time transfers and data uploads for auditing and reference purposes. Support: Provide support to the operations team with other data entry tasks as needed. Requirements Education: Bachelor's degree in business administration, Operations Management, Accounting or Finance or a related field. Experience: 0-2 years of experience in data entry or operations roles, preferably in a corporate environment. Skills: Attention to Detail: Exceptional accuracy and attention to detail in data entry. Analytical Skills: Ability to analyze data and identify discrepancies. Communication: Strong verbal and written communication skills. Technical Proficiency: Familiarity with ERP systems and proficiency in Microsoft Office Suite (Excel, Word, etc.). Time Management: Ability to manage multiple tasks and meet deadlines. Team Player: Collaborative attitude and ability to work effectively in a team environment. Technical Proficiency: Proficient in Microsoft Office Suite, with strong Excel skills including formulas (e.g., VLOOKUP, IF, SUMIFS), pivot tables, and data validation. Familiarity with ERP systems is a plus. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Senior Central Monitor

Bangalore Urban, Karnataka, India

5 years

Not disclosed

Remote

Full Time

Senior Central Monitor - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5684 Position Summary The Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaning Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 5 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Principal Central Monitor

Bangalore Urban, Karnataka, India

8 years

Not disclosed

On-site

Full Time

Principal Central Monitor - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5683 Position Summary The Principal Central Monitor serves as a strategic leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM). This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders. Operating at the highest level of subject matter expertise, the Principal Central Monitor oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios. This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement. In addition to managing escalations and complex data review activities, the Principal Central Monitor mentors senior & junior colleagues, contributes to global process innovation, and plays a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities organizationally. Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Advanced Centralized Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks. Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance, in collaboration with functional team leads and PM RBQM Meetings: Lead facilitation monthly RBQM meetings, bringing together key stakeholders to review and discuss study data, findings, action plans and coordination of data cleaning activities to support study deliverables. Drive the review of key risk indicators (KRIs), data trends, and issue resolution plans. Provide expert guidance on data cleaning prioritization to meet critical study milestones. Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Mentor teams on proactive data monitoring techniques and lead initiatives to continuously improve data integrity and efficiency. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: lead discussions with Sponsors around risk management and proactive data cleaning Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar & scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Central Monitor II

Bangalore Urban, Karnataka, India

2 years

Not disclosed

Remote

Full Time

Central Monitor II - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5687 Position Summary The Central Monitor II will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor II may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: support monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Senior Contracts Manager

Itanagar, Arunachal Pradesh, India

5 years

Not disclosed

Remote

Contractual

Senior Contracts Manager - Location: Remote Remote India Remote Remote India Job Type: regular full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5643 Position Summary The Senior Contract Manager plays a critical role in our ability to achieve our goals by creating, managing and maintaining strong relationships with business teams and establishing client and vendor contracts for those business teams. In this role, they will be responsible for contract negotiation, closeout, extension and renewal, and will communicate contractual changes and their context for the particular business to all stakeholders. Essential functions of the job include but are not limited to: Reviewing, drafting and negotiating all the commercial agreements between the business and their clients and vendors, including master services agreements, consulting agreements, independent contractor agreements, confidentiality agreements, work orders, change orders and other client or vendor contracts, and escalating complex issues to the corporate legal team. Ensuring adherence to company policies, procedures and contracting standards. Ensuring that the relevant leadership and business teams are apprised of the status of contract negotiations and execution. Coordinating execution of agreements and keeping track of expirations and other obligations. Assisting in the design and maintenance of contract files and databases. Assisting in designing and implementing policies and procedures to affect the timely execution of contracts. Recognizing where processes can be improved and taking initiative to improve them. Other tasks, as assigned. Qualifications: Minimum Required: Post Secondary Degree or Certificate Minimum of 5 years relevant experience drafting, reviewing and negotiating commercial contracts, preferably in the life science or pharmaceutical industry Other Required Strong organizational skills and the ability to multi-task and prioritize in a fast-paced environment, working on time-sensitive matters while maintaining accuracy and attention to detail Well-developed interpersonal skills Good judgment and a proactive and independent work style Proven ability to meet deadlines on multiple projects Ability to work cross-functionally with various team members at different levels of the organization Strong working knowledge of Microsoft Office programs (Word, Excel, Outlook) Must be able to read, write, speak fluently and comprehend the English language It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

AI Architect

Itanagar, Arunachal Pradesh, India

12 years

Not disclosed

Remote

Full Time

AI Architect - Location: Remote Remote India Remote Remote India Job Type: regular full-time Division: Precision for Medicine Business Unit: QuartzBio Requisition Number: 5716 QuartzBio Overview QuartzBio (www.quartz.bio ) is a Software-as-a-Service (SaaS) solutions provider to the life sciences industry. We deliver innovative, data enabling technologies (i.e., software) that provide biotech/pharma (R&D) teams with enterprise-level access to sample/biomarker data management solutions & analytics, information, insight & reporting capabilities. Our end-to-end (from sample collection to biomarker data) suite of solutions are focused on providing sponsors information (data with context) – we do this by connecting biospecimen, assay as well as clinical data sources in a secure and scalable cloud-based infrastructure, enabling seamless, automated data management workflows, key insight development, improved collaboration, and the ability to make faster, more informed decisions. Position Summary As AI Architect , you will play a pivotal role in defining and delivering the architecture, strategy, and execution of advanced GenAI systems that power our core products and enable intelligent exploration of biomarker data. You will lead the technical direction of the AI engineering function, ensuring cross-team alignment and driving long-term roadmap planning. In this leadership role, you will architect complex, scalable GenAI pipelines, guide technical design across squads, and influence executive-level decision-making around AI strategy, tooling, and infrastructure. You will also champion best practices in AI-first development, mentor engineering talent, and drive the adoption of emerging AI technologies to ensure our systems remain at the forefront of innovation. Key Responsibilities Architect and lead the development of next-generation RAG systems using vector databases, semantic embeddings, and cloud-native services. Design and implement scalable, production-ready GenAI pipelines and LLM-based services to power intelligent, conversational exploration of biomarker data. Collaborate across Product, Engineering, and Design to align AI architecture with roadmap priorities and user needs. Own key architectural decisions around model orchestration, latency optimization, prompt design, and scalability Strategic technical advisor to leadership and help prioritize AI investments with long-term impact. Provide technical leadership across squads, driving design reviews, AI solution quality standards, and architectural consistency. Lead internal initiatives to adopt and evaluate emerging AI/LLM frameworks, orchestration platforms, and foundation models. Define and refine LLM evaluation frameworks, feedback pipelines, and end-user quality metrics. Champion best practices for AI-first development, observability, versioning, and experimentation Serve as a mentor and multiplier, developing talent across the AI engineering organization. Drive strategic AI initiatives aligned with business goals. Subject matter expert in AI and machine learning technologies. Draft and maintain internal documentation for relevant AI systems and processes; communicate within and across teams. Debug and troubleshoot complex AI system issues and provide timely solutions. Mentor and develop AI engineers; help scale the AI organization through strategic hiring, training, and leadership. Communicate effectively with team members and stakeholders. Collaborate with cross-functional teams to define AI project requirements and timelines. Continuously improving technical skills and staying up to date with emerging AI technologies and shifting priorities Other duties as assigned. Qualifications Bachelor’s degree related field and a minimum of 12 years of relevant work experience in cloud/infrastructure technologies, information technology (IT) consulting/support, systems administration, network operations, software development/support, technology solutions. 10+ years of engineering experience, including 5+ years shipping production ML/AI systems, with a focus on LLMs or GenAI 6-8 years of experience working in a customer-facing role and leading projects. Proven experience driving architecture and strategy for complex AI systems at scale Deep expertise in Python, cloud platforms (especially AWS), and modern AI/ML infrastructure Advanced proficiency with semantic search, vector databases, and retrieval-augmented generation (RAG) architectures Experience working with LLM tooling such as Lang Chain, Llama Index, AWS Bedrock, OpenAI, or similar Familiarity with evaluation pipelines, human-in-the-loop feedback systems, and performance optimization Strong systems thinking and algorithmic fundamentals (DSA) Excellent communication skills, with a track record of aligning stakeholders and driving strategic initiatives. Comfortable in AI-native environments using tools like GitHub Copilot, Cursor, or related development assistants. Strong ability to identify and present information or data that will have a strong effect on others. Strong ability to partner with customers. Strong ability to review and understand end-to-end work processes. Skilled at collaborating with customers to understand their requirements and expectations by asking questions and listening. Excellent problem-solving and analytical skills. Leadership Expectations Follows Company's Principle and code of ethics on a day-to-day basis. Shows appreciation for individual talents, differences, and abilities of fellow team members. Listens and responds with appropriate actions. Leads change initiatives and continuous process improvements. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Financial Analyst

Pune, Maharashtra, India

3 years

None Not disclosed

On-site

Full Time

Financial Analyst - Location: Pune Maharashtra India Pune Maharashtra India Job Type: Regular Full-time Division: Precision AQ Business Unit: Precision AQ Corporate Requisition Number: 5725 Monthly Reporting Responsibilities will include, but not limited to: Performing monthly variance analysis with forecast to actuals and recommending actions to management. Creation of financial presentation for executive management. Preparing the financial reporting portions of monthly financial reporting packages Ad-hoc analysis and collaboration with other teams. Preparation of monthly, quarterly, and annual budget forecasting cycles and working with department managers to collect inputs and perform analytical reviews and of financial dashboards and reporting of key performance measurements using accurate and quality data. Metrics & Finance Reporting Managing complex financial models including reporting holistic project profitability and being able to present findings to leadership. The ability to deep dive into departmental reporting. Review and recommendations of expense saving exercises. Documenting processes, recognizing areas of process improvement, and implementing streamlined procedures. Minimum Required What we are looking for: Bachelor’s degree with concentration in accounting or finance and 3+ years practical experience. Advanced PowerPoint and Microsoft Excel skills (including experience of working with XLookups, Pivot tables and data consolidations) Experience of using MS PowerBI The Ideal Candidate Will Also Have Excellent financial modelling capabilities, ability to handle large datasets, strong communication skills that inform stakeholders of key information as well as escalating issues in a timely manner. Ability to handle multiple projects at a time, focused on the details while finding creative ways to take on big picture challenges. With your analytics and financial acuity, you'll liaise between the Finance team with the functional areas it supports. Employee will understand the value of the finance & accounting function working symbiotically to support a growing company and you can be relied on to provide your opinion and point of view. Other Required Skills to include strategic thinking, time management, interpersonal, critical thinking, analytical, interpretative and problem-solving. Processing and analysis of large volumes of qualitative and quantitative information. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now Show more Show less

Clinical Data Associate II

Bangalore Urban, Karnataka, India

2 years

None Not disclosed

On-site

Full Time

Clinical Data Associate II - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5252 Job Description Position Summary: The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities. Essential functions of the job include but are not limited to: Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Assist with coordinating SAE/AE reconciliation Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 2+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Preferred Experience in a clinical, scientific or healthcare discipline. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

Senior CloudOps Engineer

Itanagar, Arunachal Pradesh, India

4 years

None Not disclosed

Remote

Full Time

Senior CloudOps Engineer - Location: Remote Remote India Remote Remote India Job Type: Regular Full-time Division: Precision AQ Business Unit: Product Solutions Requisition Number: 5762 Sr CloudOps Engineer Position Summary The Senior CloudOps Engineer is a hands-on technical role that directs and implements the setting up of the necessary infrastructure for the business. It also includes the automation of all manual tasks for the building and deployment of code, data, and other assets; particularly Azure AI Services for all parts of our internal business.. This individual will automate development and infrastructure processes so that we can seize opportunities without compromising quality. The candidate will interact with application development teams, product owners, infrastructure architects, and other business stakeholders to support their needs and to also review / identify and then implement processes that eliminate or reduce the need for manual intervention. The ideal candidate will champion the CloudOps as well as DevOps culture and be the change agent to help to foster a cultural shift in the software delivery process. Along with automation, they will focus on improving communication and collaboration that facilitate iterative improvement. Essential functions of the job include but are not limited to Collaborate with development and other cross-functional teams to create and maintain Infrastructure and related documents for platforms, products, and client specific solutions enabled by AI tools. Design and develop tools for managing and applying automated infrastructure setup and deployment pipelines (CI/CD) Improve and Optimize existing infrastructure based on metrics and analytics derived from past implementations, and by working with Corporate IT CloudOps teams Work with their managers to maintain cost efficiency and work on Cost Optimization whenever possible Work with Azure/vendors/IT to perform WAFR, and take necessary action to keep he score high Configures and maintains all components of the Infrastructure (primarily Azure) Follows established procedures for change management across applications where changes are necessary Creates documentation such as WIKI articles for common processes that are repeated and can be shared with others Researches and makes recommendations regarding new automation technology available and its proper application Prepares effort estimates for any work undertaken Qualifications Bachelor’s degree in engineering (B.E.) or in Technology (B. Tech.). Degree in computer science or related fields preferred. Minimum Required Experience building and managing infra for Azure Open AI services Experience building and managing AI Studio 4+ years developing and implementing cloud infrastructure and building pipelines 5+ years of experience with information technology Experience working with various software development tools, open-source technologies, and Azure cloud services Other Required Experience setting up various Azure tools and services – network, security, computes etc. Experience working with a team following Agile software development lifecycle practices Experience working with GitLab, Azure DevOps, Jira or similar systems for software development lifecycle management, source control, branching, and/or CI/CD pipelines Understanding of concepts and tooling for containerization and orchestration (i.e. Docker, Kubernetes) Agile software development experience May require travel domestically and/or internationally including overnight stays up to 5%” Preferred Working knowledge of US Healthcare / Market Access would be an advantage. Experience with both AWS and Azure applications and services – S3/Blob, Ec2/VM etc. Knowledge of Python, Shell It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

Senior Clinical Data Manager

Bangalore Urban, Karnataka, India

10 years

None Not disclosed

On-site

Full Time

Senior Clinical Data Manager - Location: Bangalore Karnataka India; Chennai Bangalore Karnataka India; Chennai Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5838 Position Summary The Clinical Data Manager/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 10+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

Senior Software Engineer

Itanagar, Arunachal Pradesh, India

5 years

None Not disclosed

Remote

Full Time

Senior Software Engineer - Location: Remote Remote India Remote Remote India Job Type: regular full-time Division: Precision for Medicine Business Unit: QuartzBio Requisition Number: 5809 QuartzBio Overview QuartzBio (www.quartz.bio ) is a Software-as-a-Service (SaaS) solutions provider to the life sciences industry. We deliver innovative, data enabling technologies (i.e., software) that provide biotech/pharma (R&D) teams with enterprise-level access to sample/biomarker data management solutions & analytics, information, insight & reporting capabilities. Our end-to-end (from sample collection to biomarker data) suite of solutions are focused on providing sponsors information (data with context) – we do this by connecting biospecimen, assay as well as clinical data sources in a secure and scalable cloud-based infrastructure, enabling seamless, automated data management workflows, key insight development, improved collaboration, and the ability to make faster, more informed decisions. Position Summary As we continue to expand our software engineering team, we are seeking a highly experienced Software Engineer. You will work with a team of software engineers to design, develop, test and maintain software applications. The successful candidate will have a strong understanding of software architecture, programming concepts and tools, and be able to work independently to solve complex technical problems. In your role as Senior DevOps Engineer You will lead the design and implementation of scalable infrastructure solutions. You’ll mentor junior engineers and drive automation and reliability across our AWS environments. Key Responsibilities Manage projects and initiatives with moderate complexity. Collaborate with cross-functional teams to design, develop, test, and maintain software applications. Create design specifications, test plans and automated test scripts for individual work scope. Develop software solutions that are scalable, maintainable, and secure. Analyze, maintain, and implement (including performance profiling) existing software applications and develop specifications from business requirements. Understand the purpose of new features and help communicate that purpose to team members. Write and debug software systems in accordance with software development standards, including the Application Development Lifecycle. Debug and troubleshoot complex software issues and provide timely solutions. Implement new software features and enhancements. Ensure adherence to software development best practices and processes. Write clean, legible, efficient, and well-documented code. Lead code reviews and provide constructive feedback to peers. Help to support the work of their peers by pair programming, reviewing code, and through mentorship. Mentor junior team members and provide guidance. Continuously improve technical skills and stay up to date with emerging technologies. Communicate effectively with team members and stakeholders. Contribute to strategic planning and decision-making. When performing duties as Senior DevOps Engineer Lead the development and maintenance of the Terraform IaC repository, ensuring modularity and scalability. Design and implement deployment strategies for microservices on Kubernetes (EKS) using Helm. Provision new applications and environments, ensuring consistency across dev, staging, and production. Optimize CI/CD pipelines in GitLab, integrating with Kubernetes and Docker workflows. Manage and monitor Kubernetes clusters, pods, and services. Collaborate with engineering teams to standardize development tools and deployment technologies. Mentor junior engineers and contribute to architectural decisions. Identify opportunities to streamline and automate IaC development processes. Other duties as assigned Qualifications Bachelor’s degree related field and a minimum of 5 years of relevant work experience in cloud/infrastructure technologies, information technology (IT) consulting/support, systems administration, network operations, software development/support, technology solutions. 2-4 years of experience working in a customer-facing role and leading projects. Excellent problem-solving and analytical skills. Strong written and verbal communication skills. Ability to articulate ideas and write clear and concise reports. Role qualifications: For Senior DevOps Engineer 5+ years of DevOps experience. Deep expertise in AWS services and Terraform. Strong scripting and automation skills. Experience with container orchestration (EKS, Kubernetes) and Helm Charts. Experience with CI/CD tools, specifically GitLab. Leadership Expectations Follows Company's Principles and code of ethics on a day-to-day basis. Shows appreciation for individual talents, differences, and abilities of fellow team members. Listens and responds with appropriate actions. Supports change initiatives and continuous process improvements. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

Senior Software Engineer

Itanagar, Arunachal Pradesh, India

8 years

None Not disclosed

Remote

Full Time

Senior Software Engineer - Location: Remote Remote India Remote Remote India Job Type: regular full-time Division: Precision for Medicine Business Unit: QuartzBio Requisition Number: 5848 QuartzBio Overview QuartzBio (www.quartzbio.com) is the Precision Medicine Intelligence Company. Our first-in-class Precision Medicine AI Agent Platform enables autonomous data ingestion and conversational insights across the precision medicine value chain. Powered by a network of domain-specific AI agents, our solutions amplify the efforts of operations, translational, informatics, and IT teams, using AI-driven integration of biomarker, sample, and clinical data to create a unified, scalable data ecosystem. R&D teams can shorten time from data to insights, analytics, and visualizations, accelerating study close and time-to-market. Transform the way precision medicine teams work with 360° intelligence. Position Summary We are seeking a highly skilled and motivated Software Engineer (Backend Development) to join our Foundational Data Pipelines Development team. This role is ideal for someone who thrives in a collaborative environment, enjoys working with complex legacy systems, and is passionate about building scalable, maintainable, and testable software solutions. You will work closely with other engineers and stakeholders to design, develop, test, and maintain backend applications and data pipelines. You will play a critical role in translating client needs into robust software features and contribute to the development of high-quality R and Python packages. Key Responsibilities Proven expertise in R and Python backend development, including R package creation and adherence to community best practices. Design and implement clean, efficient, and well-documented code with a strong emphasis on robustness and testability. Skilled in unit testing, debugging complex software issues, and delivering timely, testable solutions. Strong experience with Git, version control workflows, and working in Linux environments using command-line tools. Navigate and debug a multi-repository codebase using command-line tools and Git. Proficient in SQL and relational databases. Contribute to the design of relational data models that reflect real-world data collection processes, particularly in clinical trial contexts. Analyze, maintain, and enhance existing software applications while implementing new features. Translate client requests into reliable and maintainable software features, with an understanding of both service and SaaS business models. Proactively engage with internal experts, documentation, and legacy code to refine and clarify specifications. Collaborate with cross-functional teams to design, develop, test, and maintain software applications. Create design specifications, test plans, and automated test scripts for individual work scope. Write and debug software systems in accordance with software development standards, including the Application Development Lifecycle. Ensure adherence to software development best practices and processes. Demonstrated ability to lead technical projects independently, including planning, execution, and delivery. Leads complex technical projects with minimal oversight. Accountable for delivering work on time and within scope, contributing to overall project success. Experience coordinating across teams, managing technical dependencies, and communicating project status to stakeholders. Strong written and verbal communication skills. Ability to write clear, concise, and technically complex reports and documentation. Demonstrated leadership in driving technical initiatives and mentoring peers. Serves as a technical resource and mentor within the team. Provides input into technical direction and process improvements. Demonstrated initiative in continuous learning and staying current with emerging technologies. Other duties as assigned. Qualifications Bachelor’s degree related field and a minimum of 8 years of relevant work experience in cloud/infrastructure technologies, information technology (IT) consulting/support, systems administration, network operations, software development/support, technology solutions. 4-6 years of experience working in a customer-facing role and leading projects. Proven expertise in R and Python backend development, including R package creation. Skilled in unit testing, debugging, and writing clean, testable code. Strong experience with Git, version control workflows, and working in Linux environments using command-line tools. Proficient in SQL and relational databases. Demonstrated ability to lead technical projects independently, including planning, execution, and delivery. Leads complex technical projects with minimal oversight. Accountable for delivering work on time and within scope, contributing to overall project success. Basic knowledge of project management processes and tools (e.g. project scheduling, budgeting, status reporting). Experience coordinating across teams, managing technical dependencies, and communicating project status to stakeholders. Strong written and verbal communication skills. Ability to write clear, concise, and technically complex reports and documentation. Demonstrated leadership in driving technical initiatives and mentoring peers. Serves as a technical resource and mentor within the team. Provides input into technical direction and process improvements. Demonstrated initiative in continuous learning and staying current with emerging technologies. Other duties as assigned. Preferred Skills Working knowledge of SQL dialects and relational data modeling. Familiarity with tools such as GNU Make, Docker, GitLab CI. Experience with R object-oriented programming (R6, S3). Exposure to AWS and cloud-based development environments. Understanding data engineering practices and pipeline development. Background in clinical trial data management is a plus. Leadership Expectations Follows Company's Principles and code of ethics on a day-to-day basis. Shows appreciation for individual talents, differences, and abilities of fellow team members. Listens and responds with appropriate actions. Supports change initiatives and continuous process improvements. Communicates effectively and appropriately with colleagues, supervisors and clients. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Apply Now

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