Muthu Raj
Clinical Trial | eTMF | SME | CTMS | Global Trial Clinical Strategy |
- Role
- Senior at Bristol Myers Squibb
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
Experience
Senior
Jul 2023 — Present
As a Senior Global Trial Specialist, I have successfully led cross-functional teams across multiple locations within company’s footprint. My responsibilities included mentoring team members, overseeing performance and development, and ensuring alignment with strategic trial objectives. Study timeline management and scenario planning of a study from SRA to close-out employing MS project planner cloud based online system - SPOT Lite. Extensive stakeholder management and coordinating various meetings (Inv Mtgs, Kick-off Mtgs, Study Operational meetings), as applicable. Management of applicable attributes and milestones/drivers in Veeva Vault CTMS. Supervising and coordinating the management of relevant documentation, ensuring the accuracy and completeness of the eTMF for all studies through regular TMF periodic reviews and reconciliations. Reviewing Monitoring Visit Reports (MVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Working in conjunction with Trial manager to prepare CSR administrative appendices. Working with vivid stakeholders and authoring Vendor management/oversight plan, TMF plan, Risk management plan, Trial management plan. Generating and managing reports and lists relative to the assigned studies, Participating in filing activities and any associated audits/audit responses. Managing vendors and site payment processing and tracking, as applicable. Facilitating the maintenance of study budget tracking tools and reconciling invoices with overall contract/budget and finance reports, as applicable. Supporting and working alongside with Regional clinical operation team and providing operational updates by reviewing data available in IRT and EDC system. Periodic review of protocol deviation and update of Protocol deviation assessment plan (PDAP). Mentoring and training the new joiners in the team.
Education
Tamil Nadu Doctor M.G.R. Medical University
Master's degree, Pharmacology
Tamil Nadu Dr. M.G.R. Medical University (TNMGRMU)
Bachelor of Pharmacy
Tamil Nadu Dr. M.G.R. Medical University (TNMGRMU)
Master of Pharmacy, Pharmacology
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