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About Eclinical Solutions

eClinical Solutions’ industry-leading data & analytics platform, elluminate®, and biometrics services experts help biopharma researchers at large, mid-size, and emerging life sciences organizations manage trial complexity in less time and with fewer resources. Clients get accurate and timely data insights for better decision-making – enabling them to reduce cycle times, improve productivity, easily scale, and develop tomorrow’s breakthroughs with today’s resources. eClinical is a privately-held, purpose-driven company with a global workforce and winner of the 2024 Top Workplaces USA and Culture Excellence Awards and Great Place To Work® India Certification™. Find out more at eclinicalsol.com.

Senior Software Developer-Analytics

Bengaluru

6 - 11 years

INR 12.0 - 22.0 Lacs P.A.

Hybrid

Full Time

Role & responsibilities The Senior Software Developer will work closely with product manager, Implementation Consultants (ICs) and clients to gather requirements to meet the data analysis need of a company or a client. They must have good collaboration skills. The Senior Software Developer will provide direction on analytics aspects to the team on various analytics related activities. Key Tasks & Responsibilities: Experienced in Qlik Sense Architecture design and good knowledge on load script implementation and best practices. Hands on experience in Qlik Sense development, dashboarding, data-modelling and reporting techniques. Experienced in data integration through extracting, transforming, and loading (ETL) data from various sources. Good at Data transformation, the creation of QVD files and set analysis. Data Modelling using Dimensional Modelling, Star schema and Snowflake schema. Strong SQL skills (SQL Server) to validate the Qlik sense dashboards and to work on internal applications. Knowledge on deploying of Qlik Sense application using Qlik Management Console (QMC) is a plus. Work with Implementation consultants (ICs), product manager and clients to gather the requirements. Configuration, migration, and support of Qlik Sense applications. Thoughtful implementation of Qlik Sense best practices for efficiency and re-usability. Research and utilize new technologies. Collaborate with the Software Quality Assurance (SQA) team to test the applications functionality. Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures. Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned. Other duties as assigned. Education/Language: BTech / MTech / Master of Science degree in Computer Science and/or equivalent work experience Good verbal and written communication skills Professional Skills & Experience: Minimum of 3-5 years of experience in implementing end to end business intelligence using Qlik Sense. Thorough experience in Qlik Sense architecture, design, develop, test and deployment process. Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization). Knowledge on Clinical Datasets and Standards is a plus. (eg: SDTM, CDISC (92,45,101), Q Format, Customized Data formats ..etc). Excellent understanding of relational database concepts, data modelling, and design. Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server. Strong Software Development Lifecycle experience (Agile methodology experience is a plus). Strong technical project management experience and team leadership skills including scope management, work planning and work delegation. Strong troubleshooting skills and use of defect/feature management systems. Proven ability to work independently and with technical team members (Startup environment experience is a plus). Good verbal and written communication skills. Strong analytical skills and strong decision-making capabilities. Technical Skills & Experience 3+ years of experience in Qlik Sense architecture and design 3+ years of experience in develop, test and deploy of Qlik Sense applications. 3+ years with SQL Server and ETL process. 3+ years with Data modelling (physical & logical). Experience with Performance tuning and best practices of Qlik Sense. Experience with Dimensional modelling, Star Schema and Snowflake Schema. Knowledge of clinical trial data and SDTM standards is a plus. Preferred candidate profile

Clinical Data Manager

Bengaluru

7 - 12 years

INR 15.0 - 22.5 Lacs P.A.

Hybrid

Full Time

Role & responsibilities: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Technical Skills: Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards Preferred candidate profile: 5+ years’ experience in Clinical Data Management preferred. Bachelor’s degree in a health-related field or equivalent experience preferred. CCDM Certification preferred.

Senior External Data Specialist

Bengaluru

6 - 11 years

INR 12.0 - 22.0 Lacs P.A.

Hybrid

Full Time

Role & responsibilities: Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders. Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues. Communicate to vendors and client issues involving external data transfers, data point issues and validation issues. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality. Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture. Ensure clinical database supports data requirements and is in alignment with external vendor data. Position: Senior External Data Specialist Job Description Template TEMP-104 v1.0 Perform QC of external data test transfers for acceptance. Maintain data transfer agreement set-up logs, reconciliation logs and/or change logs. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database. Review external vendor data and/or local laboratory data listings via elluminate and issue queries or communicate data issues to internal and/or external team members. Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented. Perform local lab and external vendor associated study start-up and build activities. Perform IST activities for local lab normal range population. Develop the local lab and external data exception listing specifications and QC the output for movement to production. Drive the set-up and implementation of external vendor data transfer agreements and specifications, working closely with the client, vendors, and functional teams. Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management. Report client and/or study level local lab and/or external vendor data driven units to Project Management for scope monitoring. Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes. Identify and recommend process improvements, working with functional team leads and management for developing, reviewing, and implementing processes and guidelines for external data and local lab data processing. Support management for reporting of external data and local lab KPIs and performance metrics Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactively identify and mitigate risks. Contribute to digital transformation in external data management, leveraging emerging technologies to streamline process, ensure compliance and stay at the forefront of industry advancements. Utilize technology including AI ML and advanced analytics to perform real time monitoring to proactively identify and address data discrepancies, ensuring accuracy, integrity, and quality of various external and local lab data. Facilitate external and local lab data cross-functional team training. Professional Skills & Experience 5+ years experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Ability to maintain confidentiality of data and information during interactions with staff at all levels. Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Basic understanding of medical terminology Excellent team player and collaborator Ability to work independently and manage multiple projects Detail oriented, ability to multitask, with strong organizational skills. Strong communication skills. Knowledge of clinical data management processes and vendor data processing Familiarity with various 3rd party vendors and data transfers. Understands a variety of external data types and methodologies. Strong leadership and mentoring skills. Considerable experience within the CRO or pharmaceutical industry. Apply using the link below. https://grnh.se/q396oq2f7us

Data Engineer

Bengaluru

3 - 5 years

INR 8.0 - 16.0 Lacs P.A.

Hybrid

Full Time

OVERVIEW The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper and Qlik. The position involves a high level of quality control as well as adherence to standard operation procedures and work instructions and a constant drive towards automation and process improvement. KEY TASKS & RESPONSIBILITIES Design, develop, test, and deploy highly efficient code for supporting SDTM, Custom reports and Visualizations using tools like MS SQL, elluminate® Mapper and Qlik Configure ETL processes to support of the aggregation and standardization of clinical data from various sources including EDC systems, SAS and central laboratory vendors Work with Analytics developers, other team members and clients to review the business requirements and translate them into database objects and visualizations Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned Provide diagnostic support and fix defects as needed Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Other duties as assigned CANDIDATE’S PROFILE Education & Experience 3+ years of professional experience preferred Bachelor's degree or equivalent experience preferred Experience with database/warehouse architecture, design and development preferred Knowledge of various data platforms and warehouses including SQL Server, DB2, Teradata, AWS, Azure, Snowflake, etc. Understanding of Cloud / Hybrid data architecture concepts is a plus Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus Professional Skills Critical thinking, problem solving and strong initiative Communication and task management skills while working with technical and non-technical teams (both internal to eCS and clients) Must be team oriented with strong collaboration, prioritization, and adaptability skills Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions Excited to learn new tools and product modules and adapt to changing technology and requirements Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Technical Skills Proficient in SQL, T-SQL, PL/SQL programing Experience in Microsoft Office Applications, specifically MS Project and MS Excel Familiarity with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related

UiPath RPA Developer

Bengaluru

3 - 6 years

INR 12.0 - 13.0 Lacs P.A.

Work from Office

Full Time

OVERVIEW Centre of Automation (CoA) team will be undertaking RPA projects and initiatives internally within the company. The RPA Developer will be the key resource for design and development in the team. In this role, you will participate in all phases of the project cycle, including technical planning, SOP review, designing and building automation package and post-project maintenance. This role will also support existing automations. KEY TASKS RESPONSIBILITIES Develop an RPA architecture and a solution proposal focused on scalability and extensibility. Design, build, test and implement robotics and process automation in support of business requirements, software, and industry best practices. Deploy RPA Components including Bots, Development Tools, Code Repositories and Logging Tools. Launch and Implementation of RPA Solutions. Responsible and accountable for maintaining the RPA Object Library. Serve as final escalation point for automation execution and issues. Create Process and End-User Documentation. Support deployments or troubleshoot production issues Provide support ensuring swift resolution and minimal impact to business operations. Optimize bot settings proactively to reduce the risk of failures and minimize downtime. Maintain and update Root Cause Analysis (RCA) documentation for all incidents to support continuous improvement, transparency, and knowledge sharing. CANDIDATE S PROFILE Education/Language: BSc./B.E/B.TECH in Computer Science/IT or equivalent or MCA preferred. Fluency in English Professional Skills Experience 3-6 years of overall IT experience preferred. 3-5 years of experience in RPA development using UiPath preferred. Experience with other automation tools like Automation Anywhere, Blue Prism, Automation 360 etc. Proficiency with programming tools including SQL, PowerShell, Python, and/or C#, Strong working relationships with team members, stakeholders, and management. Ability to work independently, with limited supervision, whilst participating fully as a member of the RPA team. Able to design technical specification documents for RPA Projects. Good understanding of various automation components and features in RPA. Ability to translate requirements into processes and controls. Demonstrate strong collaboration across all levels of the organization. Strong analytical skills, coupled with a logical, disciplined, and structured approach to documentation and procedures. UiPath RPA Developer certification is preferred, but not mandatory. Hands-on experience in configuring and managing system integrations (e.g., ERP, CRM, third-party APIs). Exposure to AI/ML integration, including working with services like OCR, NLP, or predictive analytics within automation workflows.

Compliance Associate

Bengaluru

1 - 4 years

INR 3.0 - 7.0 Lacs P.A.

Work from Office

Full Time

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Compliance Associate will assist the Sr. Compliance Manager with relevant laws, regulations, and internal policies. Responsibilities will also include managing the Vendor Intake process, conducting vendor audits, and guiding other department personnel thru the vendor management process. KEY TASKS & RESPONSIBILITIES Assist the Sr. Compliance Manager with key compliance-related initiatives such as SOC2, ISO, and other related areas. Manage the Vendor Intake process by working with departmental leaders to assess / re-assess vendors as required. Provide backup support as required to the overall Quality and Compliance team. Respond to co-worker questions regarding compliance regulations and industry best practices. Represent Vendor Management in Audits and ongoing process improvements. Serve as a document coordinator owning the maintenance of Compliance documentation -SOP, WIs, Templates, Forms, ensuring content accuracy and adherence to standards. Other duties as assigned Education & Experience BS degree or job-related equivalency preferred Experience in Quality and Compliance, or similar administrative role Experience and knowledge of compliance regulations and industry best practices Experience working in a fast-paced environment preferred Professional Skills Excellent knowledge of English Strong understanding of business goals and standards for customer service Strong Presentation skills Excellent decision-making skills Strong interpersonal and communication skills Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company. Technical Skills Strong time-management and organizational skills Problem-solving skills Analytical skills Adaptable to change Attention to detail Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Quality Audit Coordinator

Bengaluru

3 - 5 years

INR 4.0 - 8.0 Lacs P.A.

Work from Office

Full Time

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections. KEY TASKS & RESPONSIBILITIES Pre-audit coordination assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms. Live audit support serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors. Post-audit follow-up compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners. Maintain audit documentation keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements. Support internal quality audits schedule, prepare, and close routine internal audits. Capture and verify records document audit interviews accurately and circulate for stakeholder confirmation. Facilitate cross-functional readiness ensure the various business units have evidence and answers prepared in advance. Assist with vendor audits assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions. Improve audit processes recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity. Update SOPs and work instructions related to audit management and inspection readiness. Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness. Education & Experience Bachelor s degree in a related field is preferred 3-5 years of experience working in a pharmaceutical industry is preferred. Knowledge of clinical trial terminology and process. Knowledge of GxP quality standards, applicable regulations, and software development risks. Professional Skills Professionalism, confidentiality, and organization. Excellent writing and typing skills. High level of organizational skills and record-keeping. Ability to work effectively under critical deadlines. Robust communication skills and attention to detail. Technical Skills Ability to pull reports or extract data when needed. Ability to easily learn various software applications. Experience with Qualio or other type of QMS tool Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Eclinical Solutions

Eclinical Solutions

|

Software Development

Mansfield MA

201-500 Employees

7 Jobs

    Key People

  • Amit Vohra

    Chief Executive Officer
  • Greg C. Smith

    Chief Operating Officer
cta

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