Job Description

Job description:- 1. Evaluates and provides recommendations on optimal TMF set-up. Drives the TMF set-up, structure, and completeness reports. 2. Actively involved in Collaborative Workspace including set-up and training for the internal or external team members, as applicable. 3. Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner Develops plans to increase compliance. 4. Designs and/or delivers study-specific TMF training in various formats. 5. Represents the TMF during Quality Finish Meetings, provides guidance to the Project Team and TMF Operations Team on performing the final QC/Completeness Review, and oversees the TMF Shipment. 6. Presents monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM). 7. Attends Trusted Process meetings such as Kick-Off, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF. Qualification required: B.Pharm/ M.Pharm/ M.Sc clinical research Experience Required: 5-8 years