Tmf Lead Ii

Summary

Join Precision Medicine Group as a TMF Lead II and oversee the management and delivery of the eTMF, ensuring compliance with GCP, ICH guidelines, and relevant regulations. You will create and execute study TMF plans, manage communication, collaborate with project teams, monitor TMF health, and perform completeness checks. Responsibilities include supporting study close-out activities and identifying training needs. This role requires a 4-year college degree or equivalent, at least 1 year of TMF/eTMF experience, and proficiency in Microsoft Office. Strong interpersonal skills and knowledge of ICH-GCP are essential.

Requirements

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
• At least 1 year of experience with TMF and/or eTM
• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
• Demonstrates solid interpersonal skills
• Demonstrates, or can be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles

Responsibilities

• Create and execute the study TMF Plan and project TMF Document Index
• Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF
• Attend and contribute to project internal to ensure they are aware of the status of the eTMF, gaps, and escalations
• Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality to maintain the TMF in an inspection-ready state
• Develop and recommend plans to increase compliance and follows-up on non-compliance
• Engage TMF Management when required for escalations
• Monitor and report on TMF Health to internal team and sponsor
• Identify trends, risks, and overall status of the TMF
• Initiate and perform Quarterly Completeness/Compliance checks for assigned projects and ensure proper documentation
• Identify project team TMF training needs and provides or supports team re-education
• Support the close-out activities of assigned studies, including contributing to the timeline creation for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfers to the sponsor and collects the Acknowledgement of Receipt

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation