TMF Lead

Description

• Attends Trusted Process meetings such as Kick-Off Meetings, QuickStart 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. May be supported by Senior TMF Lead.
• Provide support to TMF Lead II and Senior TMF Leads with various project-specific tasks.
• Verifies studies have been properly created and configured within the eTMF platform.
• Monitors and reports on TMF Health, including identifying risks, issues and mitigation plans for the project.
• Actively involved in the eTMF platform including providing support for the internal or external team members, as applicable.
• Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable.
• Attends internal project team and sponsor teleconferences as applicable to the project.
• Prepares and participates in project-specific audits/inspections to ensure ongoing inspection-readiness of the TMF. May be supported by Senior TMF Lead.
• Provides regular feedback to the Project Team on TMF Health, including actionable metrics. Provides project-specific re-training to the Project Team, as necessary, based on TMF trends. May be supported by Senior TMF Lead.
• Provides timelines to the Project Team and TMF Operations

Qualifications