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 prospects 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