TMF Lead II

Job Description

Position Summary:

The TMF Lead II is responsible for oversight, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The TMF Lead II support smaller and/or less complex studies. Essential functions of the job include but are not limited to:

Essential Functions of the job include but are not limited to:

• Creates and executes the study TMF Plan and project TMF Document Index. Ensures entire study team understands expectations, project-specific aspects of the TMF, and manages communication of any changes in the TMF.
• Attends and contributes to project internal to ensure they are aware of the status of the eTMF, gaps, and escalations.
• Engages and collaborates 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. Develops and recommends plans to increase compliance and follows-up on non-compliance. Engages TMF Management when required for escalations.
• Monitors and reports on TMF Health to internal team and sponsor. Identifies trends, risks, and overall status of the TMF.
• Initiates and performs Quarterly Completeness/Compliance checks for assigned projects and ensures proper documentation.
• Identifies project team TMF training needs and provides or supports team re-education.
• Supports 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.

Qualifications:

Minimum Required:

• 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.

Other Required:

• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)

Skills:

• Demonstrates solid interpersonal skills.
• Demonstrates, or can be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.

Competencies:

• 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