Vikas Dalavi Email & Phone Number

Key Responsibilities:• Writes and edits SOPs and supporting documents to keep current with industry changes on eTMF management, quality and archival.• Evaluates and provides recommendations on optimal eTMF set-up. Drives the eTMF set-up, structure, and completeness reports.• Liaison between Biorasi eTMF and Veeva to perform/oversight configuration. • Close interaction with Client to execute eTMF Migration Plan.• Work as eTMF System Superuser/ Admin/Vault Owner.• Work with the Director of Clinical Operations, Project Management, and Development to recommend new features and functionalities.• People Management, resource allocation.• Train internal or external team members on eTMF systems, also designs and/or delivers study specific eTMF training.• eTMF Subject Matter Expert (eTMF SME) to the client in Veeva Vault Platform and any other eTMF system.• Provide support to ongoing and ad-hoc eTMF projects and initiatives.• Prepares and participates in audits/inspections to ensure ongoing readiness of the eTMF.• Work on CAPA measures to ensure full proof delivery of eTMF Processes.• Setup and provide daily operational metrics and lead the client/Internal meeting to provide status of daily volume accomplish and plan for future delivery and forecast.• Generate and maintain study-specific eTMF management plans and contents lists in collaboration with functional area study team members.• Collaborates with the Project Manager, Clinical Trial Manager, and other functional leads (e.g., data management; biostats; medical writing, supply chain, etc.) to ensure eTMF documentation is submitted/published in a timely manner and with high quality in order to maintain the eTMF in an audit/inspection-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable.• Conduct trainings for new employees and re-training for team members as required on an ongoing basis.• Grant/Revoke Study specific eTMF Access to the project team member and keep record for the same in zip file for reconciliation purpose.• Ensures thorough understanding of contracted scope, timeline, and budget for the eTMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required.• Work on eTMF Shipment and Study Archival in Veeva Vault. • Review audit plans before finalizing with the client and ensure the internal audits are performed as per the audit plan.• Expert in eTMF operations, Clinical Process improvements and building the team.

Listed skills include Clinical Trials, Pharmaceutical Industry, Gcp, Sop, and 4 others.