TMF Study Lead

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Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMS policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times. Initiate creation of the study specific TMF Plan and Study specific TMF list in collaboration with study teams. Conduct kick-off and coordinate TMF periodic review with study team. Define expected documents for the study and maintain appropriate placeholder or Expected Document Lists in the eTMF system in collaboration with Study team (study team serve as SME for their respective departments). Work proactively and prospectively with TMF Contributors at Study, Country and Site level to ensure timely uploading of all Essential Documents in the TMF. Periodically perform risk-based reviews of the TMF by utilizing metrics and reports to assess TMF health and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule. Support study teams to resolve noncompliance with overdue quality review findings and overdue “In-Progress” eTMF documents, which will improve the accuracy of the TMF. Provide TMF oversight and coordinate TMF management activities with CRO counterpart when study is outsourced to CRO. Monitor and identify TMF trends and escalate concerns to management. Generate, organize, and deliver TMF performance metrics at the site, study, country and compound levels.  At study completion, ensure the TMF is ready to be archived. Manage complex export requests for Health Authorities and divestitures and independently solve technical issues. Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams. Assist in overall change management and build collaborative relationships with cross functional team and third-party vendors. Provide TMF training as required by study teams. Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection. Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines. Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals. Provide support to TMF implementation, internal audits and regulatory inspections. Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge other’s achievements, and collaborate with peers to meet objectives and/or timelines in a rapidly changing environment Specific Knowledge, Skills, Abilities: Strong understanding of Trial Master File (TMF) processes, including Periodic Review, Inspection Readiness, and TMF Reconciliation activities. Expertise with GCP (Good Clinical Practices), ICH guidelines, and