- Summary of Responsibilities:
- Follow all applicable departmental Standard Operating Procedures and Work Instructions.
- Complete day-to-day tasks ensuring quality and productivity.
- Track and report metrics as determined by management according to required timelines.
- Participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
- Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems & access management
- Manage study documents such as study level, country level and site level
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and support activities.
- Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
- 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.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
- Actively support compliance metrics including TMF, CTMS, and overall project health.




- Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
- Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
- Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client.
- Work with Study Team to maintain WISER moments.
- May assist with additional cross-functional tasks according to project needs.
- Initiates RIM changes, manages PCC Log, and supports documentation and impact tracking.
- Assists in vendor management activities including invoice tracker and PO requisitions.
- Handles PII assessments, system documentation and updates to XRIM as needed

Additional Responsibilities (Centralized Study Team May Perform Below Activities)

- Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
- Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements.
- Vendor Management oversight.

Learn more about our EEO & Accommodations request here.

📌 Centralized Study Coordinator (Bengaluru)
🏢 Fortrea
📍 Bengaluru