Summary of Responsibilities:
- To complete other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems and access management.
- Manage study documents and support eTMF management.
- Maintain study databases (CTMS, IWRS, EDC, etc.)
- Support study team in data review and support activities.
- Track and follow up with CRAs for outstanding issues.
- Support in generating the study specific reports.
- Manage internal/external communications.
- Assist in ensuring training compliance for study teams.
- Manage study payments (Site and Vendor).
- Data Review:
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
- Assist the Lead for any study specific data review related tasks.
- Draft and send study specific reports as per the study team instructions.
- Perform any other data review related tasks as per the project team instructions.
- Document Review:




- Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
- Review amended Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Positive Clinical Practice (GCP) guidelines.
- File amended Informed Consent Form and Investigator Package approval documentation in TMF and eTMF.
- Review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
- Study Support:
- Generate Study Reports and perform analysis.
- Perform Access management on applicable study systems.
- Perform study system set up on new awarded studies.
- CTMS compliance management.
- Manage project communications.
- Assist project teams for other study support activities.
- Investigator Payments:
- Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” in

📌 Centralized Study Analyst (Bengaluru)
🏢 Fortrea
📍 Bengaluru