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About Bioclinica

ERT, the global clinical endpoint technology leader, and Bioclinica, a technological and scientific leader in medical imaging, is now the combined company of Clario. Clario is a technology company that generates the richest clinical evidence by fusing scientific expertise and global scale into the broadest endpoint technology platform. In doing so, Clario empowers its partners to transform lives. Clario is committed to innovating the future of clinical trials through technology and having a positive impact on global healthcare.

Project Coordinator, Respiratory

Bengaluru

1 - 3 years

INR 15.0 - 16.0 Lacs P.A.

Work from Office

Full Time

Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

RFI & Content Analyst

Bengaluru

2 - 7 years

INR 2.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Are you seeking a purposeful and rewarding commercial RFI & Content career opportunity within the Clinical Research industry? Our operations in India are growing, and with big ambitions and a clear vision for the future, now is the time to join Clario s global team as an RFI & Content Analyst. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing RFI/RFQ Management Process RFI/RFQ requests through the Clario proposal response system, including but not limited to, site and device qualification forms Review responses suggested by the system for relevancy and update where necessary Investigate technical specification documentation, user manuals etc. to obtain information as required Liaise with internal SMEs to obtain information as required Ensure the timely and accurate delivery of all deliverables Database Management Management of the RFI content library Maintain accuracy of responses in the RFI content library Manage RFI/RFQ requests in Salesforce Manage the systematic SME review of stock answers through the system Manage library of SME responses within the system Internal Relationship Management Manage interactions with SMEs relating to detail gathering for RFI/RFQ through the system Manage communication, updates and expectations of Project Management and other internal requestors as required Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Supporting other functional teams with any information request needs Perform other duties as assigned What we look for Bachelor s degree, or minimum years experience required as outlined below Knowledge of Salesforce or similar CRM tool required Microsoft Office applications including Excel, Word and Access required RFI/RFQs and/or content management tools experience desirable 2+ years experience in Project or Proposal Management/Co-ordination, Relationship Management/Account Management, liaising with multi-departmental stakeholders 2+ years relevant industry experience preferred Ability to work independently or in team setting; ability to adjust to changing priorities Excellent attention and orientation toward meticulous work Strong organization skills and ability to prioritize and meet deadlines Strong interpersonal and communication skills, both verbal and written Ability to project and maintain a professional and positive attitude . EEO Statement .

Assistant Clinical Project Manager, Oncology

Bengaluru

1 - 5 years

INR 3.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Assistant Clinical Project Manager, Neuroscience

Bengaluru

1 - 5 years

INR 3.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Clinical Project Manager, Oncology

Bengaluru

2 - 5 years

INR 4.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as a Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 3 + years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Medical Imaging experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude .

Validation Analyst

Bengaluru

3 - 6 years

INR 5.0 - 8.0 Lacs P.A.

Work from Office

Full Time

Primary Responsibilities Experience in writing complex SQL queries and experience with any data visualization tool is preferable e.g., Tableau, Power BI. Good exposure of Software Testing methodologies, Implementation of Data Lakes, Data warehouse/ETL projects , Big Data projects in On-Premises & Cloud Environments Experienced in SAS applications and Python Programming Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Experience in ALM Tools like JIRA, TFS (Azure Devops) & Confluence. Knowledge on data quality fundamentals and data governance concepts. Hands-on experience with all levels of testing includes Smoke Testing, Integration Testing, System Testing and Regression Testing. Knowledge of PL-SQL, PySpark & SQL, on framing and tuning the Queries so that it covers all the data scenarios. Accountable for high quality and on time delivery for task assigned. Qualifications: Education: Bachelor s degree required in computer sciences, or equivalent and relevant work experience in a software Testing environment. Experience: Around 3 to 6 years of experience in Software Quality Testing. Prior testing experience with pharmaceutical related software, preferred. In-depth understanding of software quality assurance, preferably in a Clinical Data environment. Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Knowledge and understanding of the Software Development, Life Cycle (SDLC) testing methodology and document management. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Experience in writing test cases based on product requirements. Experience working closely with development and business teams to communicate problem impacts and to understand business requirements. Shows creativity and initiative to improve product test coverage and effectiveness (preferred)

Assistant Clinical Project Manager

Bengaluru

1 - 4 years

INR 6.0 - 10.0 Lacs P.A.

Work from Office

Full Time

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Lead Data Manager

Bengaluru

5 - 10 years

INR 12.0 - 16.0 Lacs P.A.

Work from Office

Full Time

Lead Data Manager - ERT Legacy In addition to ensuring high quality data is provided to the Sponsors, the Lead Data Manager takes an active role in developing employees by providing mentoring and training on Clario processes and systems, and oversight and support to ensure DM staff successfully perform their daily duties. ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee assigned team: Direct the hiring, orientation, and training for the Clinical Data Management team members. Perform routine employee evaluations. Mentor and develop employees to prepare them for future growth opportunities within the company. Provide mentoring and organize training on new equipment, processes, or systems, including new hire orientation and introduction. Organize the process to ensure that the team s data management files are current and complete. Support routine status meetings with Sponsor/CRO and internal teams for your staff. Monitor the productivity and quality of the Clinical Data Management team: Develop method to track and report key quality indicators, productivity, successful data delivery, and query metrics. Conduct routine reviews with Managers, Supervisors and staff on production and key quality indicators. Support the assigned employees in setup of edit checks and proper auctioning of edit check output Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns. Define the Data Management Plan (DMP) through collaboration with clients, Project Management and Account Management. Through interactions with the Sponsor and Clinical Data Programming department, provide support to the DM team members in development, review, and finalization of data transfer requirements. Ensure the quality of study set-ups by participating in the review and approval process for all Data Management owned modules. Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times. Assist in the preparation of monthly reporting by providing metrics as required Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions, and Departmental Training as needed. Create and or/review and approve SOPs and SWIs to ensure best practices are defined and followed during the lifecycle of a study. Assist Business Development and Quality Assurance with internal and external client meetings and audits and support Clinical Data Management team at such meetings. OTHER DUTIES AND RESPONSIBILITIES: Support clear and effective communication with Sponsor and other Clario departments in the single projects (e.g. Project status, timelines, etc.) Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation Job Profile Job Description Lead in resolving Quality Event issues related to study-specific data management activities Work with the Director to develop training programs Administer training as needed QUALIFICATIONS AND SKILLS NEEDED: Education : BS/BA degree in Life Sciences or related field preferred Experience : 5 + years Data Management related experience Prior leadership experience a plus Proficient in Microsoft Office applications Strong organizational, interpersonal, time-management, and problem-solving skills with good leadership abilities Ability to manage multiple priorities Strong attention to detail Previous SAS or SQL exposure or experience a plus Excellent communication skills and ability to work well with others Ability to communicate effectively in English We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Business Administrator

Bengaluru

3 - 4 years

INR 6.0 - 10.0 Lacs P.A.

Work from Office

Full Time

BASIC PURPOSE:To manage the completion of administrative tasks required in the day-to-day operation of the Client Education team. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1) Manage the purchase and invoicing process for any costs incurred during the development of client training or operational management of the Client Education team. This includes: Identify budget required for cost Initiate purchase order Review and approve invoices Update study budget files accordingly 2) Monitor and report on expenses related to consultant use to conduct live training 3) Prepare and deliver any reports requested or contracted for clients 4) Oversee the invoicing for any client training deliverables. 5) Manage the software and device distribution and costs for the Client Education team. 6) Maintain and support any automation or databases used by the Client Education team. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : Associates degree or equivalent in business administration, finance, or human resources Experience : 3-4 years of experience in similar job position Strong organization and time-management skills, and attention to detail Excellent verbal and written communication and interpersonal skills Independent working Working conditions: Other: Computer work for long periods of time

Project Coordinator, Respiratory

Bengaluru

1 - 3 years

INR 15.0 - 16.0 Lacs P.A.

Work from Office

Full Time

Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products.

Lead Data Coordinator

Bengaluru

3 - 5 years

INR 8.0 - 13.0 Lacs P.A.

Work from Office

Full Time

Work with team members to ensure both company and department SOPs and Working Practices are being followed. Ensure protocol compliance according to documented protocol requirements. Conduct initial training of all new team members. Maintain production and quality metrics for team members. Direct the daily workflow of the team by monitoring queues and work assignments to ensure all team tasks are completed daily. ESSENTIAL DUTIES AND RESPONSIBILITIES: This position requires a minimum of 50% of the employee s time be spent performing operational tasks outlined below: Investigates and issues queries to sites/sponsors to verify/obtain demographic and visit information on ECGs, Holters and Flashcards/Transmittal Forms. Investigates and enters resolutions received from Data Clarification Requests. Maintains accurate and complete Data Coordination files for all resolutions received, including filing signed DCFs and Data Revision Request Forms in protocol and/or investigator folders. Investigates and performs Self Evident Corrections as outlined in the SEC Guidelines in the Data Coordination System Independent SWI or documented in the PRS. Performs revisions received on Data Revision Request Forms for EXPeRT Attends Project Assurance meetings and outlines feedback to Data Coordination via email. Maintains minimum departmental metrics. Assists with the Data Entry, Scanning and Barcoding procedures for the Data Acquisition team. OTHER DUTIES AND RESPONSIBILITIES: The remaining 50% of the employee s time will be allocated as follows: Monitors daily workflow of the Data Coordination and Data Acquisition Team. Maintains an accurate assessment of existing and projected workload and expected timelines. Ensures equal distribution of work to all team members. Adjusts team member assignments as required to maintain operational efficiencies. Training : Trains new staff in the daily operations of the Data Coordination Department. Assists in performing the 6 month evaluations for all new Data Coordination members. Provides feedback through routine one-on-one meetings and writes performance reviews for all Data Coordinators. Maintains daily communication between shifts. Communicates any issue that will need follow-up on another shift Communicates deadlines: Keeps all shifts adequately informed about procedure changes and workload demands. Assists in the development and maintenance of department SOPs and Working Practices. Prepares client activity metrics (paper ECGs received and processed, queries received and resolved, etc.) and any specific information regarding problematic accounts for presentation and discussion at Client Meetings. Attends, or sends a delegate to, all planning meetings. Record and distribute information relative to Data Coordination activities to the team. Present Data Coordination issues. Mentors Data Coordinators on the nuances of query resolution and issuance, including wording queries to sites/sponsor, researching issues through EXPeRT systems and the Data Cleaning Application. Oversee the daily functions of the query department to ensure that metric goals are being achieved. Track and monitor employee productivity and quality metrics. Coach DCs and DAA to achieve and exceed targets. Ensure all procedures and processes outlined in global SOPs and SWIs are adhered to. Provide training on updated SOP/SWI and system enhancements as appropriate. Ensure accurate and timely collection of demographic and visit data. Maintain workflow to meet turnaround time requirements by monitoring system queues and reports as necessary. Conduct monthly individual and team meetings to review metrics, upcoming or outstanding work and both individual and departmental goals and objectives. Report to management the conduct, efficiencies and metrics for staff performance. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : BS or BA degree in life sciences or related field or 3-5 years departmental or related experience. Experience : Strong investigational and documentation skills. Positive mentor to new and existing team members with ability to motivate co-workers. Detail oriented, with ability to prioritize. Ability to adapt to shifting demands. Excellent organizational, communication and computer skills. Good presentation skills.

Clinical Project Manager, Clinical Adjudication

Bengaluru

1 - 3 years

INR 7.0 - 11.0 Lacs P.A.

Work from Office

Full Time

Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Clinical Adjudication experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude

Medical Imaging Technologist

Bengaluru

1 - 3 years

INR 5.0 - 9.0 Lacs P.A.

Work from Office

Full Time

Clario s medical imaging expertise is unparalleled in the industry. With over 30 years of experience, we provide seamless, secure, and compliant medical imaging solutions that optimize clinical trials. Our commitment to excellence has made us a leader in the medical imaging core lab sector. We are seeking dedicated and skilled Medical Imaging Technologists to join our growing operations team in India. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Our Medical Imaging Technologists ensure Quality, including Protocol Compliance and Technical Adequacy, of Image Data by: Reviewing and analysing image data for clarity and quality Verifying image data is in compliance with project protocol requirements Generating image queries when needed Working with therapeutic team to notify Sponsor/Site for proper resolution of quality issues Assisting in archiving data for completed projects Performs other image analysis functions as may be required by: Performing client or internal demonstrations of image processing Reviewing and preparing images for submission to client and/or agency Identifies and communicates Project Requirements as they relate to the image quality review (IQR) processes by Reviewing evaluations of potential clinical research sites and verifying the accuracy of information pertaining to site personnel, medical imaging equipment, imaging protocol and data archival capabilities Providing support for technical imaging related issues Performing study initiation/technical visits to educate site personnel on image acquisition protocol, data archival, and data transmittal procedures including form(s) completion Assisting in the design and implementation of study related forms Assisting in writing and reviewing imaging guidelines/manuals Assisting in reviewing Site Surveys Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards Participating in user acceptance testing for new tools and software enhancements Participating in the modification of company SOPs related to IQR What we look for Bachelor s degree preferred 2+ years as Imaging Technologist in a imaging center or relevant clinical trial experience preferred Experience with PET is preferred Experience with X-Ray, MRI & CT modalities advantageous Experience working with computer software including Word, Excel and Access preferred Experience working with clinical trials and/or within pharmaceutical environment preferred Individuals who are able to work remotely and open to European and US time zone working hours

Bioclinica

Bioclinica

|

Pharmaceutical Manufacturing

Princeton New Jersey

1001-5000 Employees

13 Jobs

    Key People

  • John McKinley

    CEO
  • Dr. Richard Lee

    Chief Medical Officer
cta

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