Summary of Responsibilities:
- Follow all applicable departmental Standard Operating Procedures and Work Instructions.
- Complete day-to-day tasks ensuring quality and productivity.
- Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
- Track and report metrics as determined by management according to required timelines. Proactively identify opportunities for process improvements and participate in implementation.
- Ability to mentor and train others.
- Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems
- Manage study documents and support eTMF management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- 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
- Assist in study payments (Site and Vendor)
- Document and track study activities using relevant forms and tools,



as well as relevant Project Management Systems with guidance/support; including data related to Clinical, SU, and VM.
- Prepare CRA Prep Packs and send it to CRA’s before the site visit and liase with CRAs and Clinical team to resolve all outstanding queries and issues
- Address all outstanding issues for sites and provide a snapshot of issues to Clinical team including CRA’s to make the site visits more effective and effective.
- Sr. Centralized Study Analyst are expected to take a leadership role in ensuring a successful partnership with other support groups, Sr. Centralized Study Analyst are expected to help remove barriers and to facilitate success.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
- May serve as the Sr. Centralized Study Analyst on projects where there is more than one Centralized Delivery Assoc

📌 Centralized Study Specialist I (Bengaluru)
🏢 Fortrea
📍 Bengaluru