Centralized Study Analyst - Fortrea (Formerly Labcorp) - Bangalore, Karnataka, India
(2026-01)
- 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.
- Manage clinical systems C 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)
- 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 efficient.
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
- eTMF Support, QC review, eTMF upload, check and removal of duplicates, closure of DIs
- 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 C 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.
- 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 Purchase order requisitions.
- Handles PII assessments, system documentation and updates to XRIM as needed.
- Support start up team in GL preparation, review, submission and issues.
- 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.
- Exhibit Strong stakeholder management Skills including negotiation and proactive communication with sponsor, sites and project team.
Senior Centralized Study Associate - Fortrea (Formerly Labcorp) - Bangalore, Karnataka, India
(2024-12 - 2025-12)
Clinical Trial Assistant - JSS Medical Research Asia Pacific Private Limited - Thane
(2021-07 - 2024-11)
- Study Support – Maintained study trackers, PPTs, TMF TOC, prepared various study specific reports, study specific logs, ISF binder, EC dossier. Provided study related support to Sponsors, Vendors, DM, Safety, Pharmacy, QA Regulatory and Finance team.
- Essential Document Management – document collection, document review, document filing, QC Review, periodic review of eTMF.
- Site Experience – experienced as a co-monitor in IMVs and SCVs, ISF & patient file review, documentation, SDV C SDR, closeout documentation.
- Audits – supported study team in audits (Site, TMF, Pharmacy), acted as the main point of contact for TMF audit, provided support in drafting TMF audit report CAPA response.
- Site Support – Access Management – EDC, Prepared draft reports and letters, provide IP and non-IP supplies, and deliver study-related support. Assisted site in EC submissions, draft letters, EC dossier preparation, ICF customization, ICF translation, ICF review. Invoice review, assist in Site contracts draft preparation.
- Management of Meetings & Teleconferences (Scheduled, drafted and distributed client and internal meeting minutes)
- Vendor management – Vendor contracts, NDA, communication, invoices, payment reconciliation.
