Senior Trial Master File Manager (Contract-to-Hire) - BioTalent : Job Details

A late-stage biopharmaceutical company is seeking a talented Sr. TMF Manager to join them on a contract-to-hire basis.

Key Responsibilities

• Management of clinical studies to ensure timely, consistent, and quality setup and maintenance of TMF requirements and processes. This includes document QC, upload, remediation, and query management
• Ensure that the staff is appropriately trained in systems, processes SOPs, and other onboarding activities for new staff
• Develop successful working relationships with TMF stakeholders, both internal and external, also includes overseeing the TMF Specialists and ensuring they meet study deliverables
• Responsible for risk mitigation, action plans, and issue resolution along with proactively communicating changes, updates, and issues to all TMF stakeholders
• Oversight of internal and external audits and inspection activities which includes oversight of the development and timely resolution of corrective action plans related to TMF findings
• Develop lessons learned and share across programs and foster a culture of constant improvement as a TMF ambassador
• Review data quality outputs and audit outputs to identify trends; develop process improvements, includes reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate
• Attend/conduct study team and other meetings as needed
• Perform other duties as assigned such as supporting the Associate Director with projects, and initiatives, co-managing TMF education services, etc.

Additional Information:

• Hourly Pay
• 40 hours per week
• One Year Contract
• Weekly/ Bi-Weekly Pay Checks
• Benefits & 401k if needed