TMF Lead I

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Guarantee the prompt and high-standard review and processing of TMF documents, including periodic quality checks, setup, maintenance, finalization, and archival.

• Develop and implement study TMF Plans along with project TMF Document Indexes.

• Ensure that study teams comprehend TMF expectations and effectively communicate any changes.

• Confirm that TMF documentation is appropriately filed.

• Participate in and add value to project kick-off meetings, as well as internal, external, and ad hoc meetings.

• Collaborate with Project Managers and Functional Leads to uphold inspection-ready TMFs.

• Detect TMF compliance challenges and risks, execute mitigation strategies, and adhere to escalation procedures.

• Oversee and report on TMF health metrics, trends, risks, and overall status.

• Act as the primary contact and subject matter expert during project audits and inspections.

• Provide TMF analytics and expertise to Sponsors.

• Ensure that periodic quality reviews and document processing are performed for designated projects.

• Recognize TMF training requirements and deliver or support team re-education initiatives.

• Oversee study close-out processes, which include final submissions, query resolution, eTMF export, sponsor transfer, and acknowledgment of receipt.

• Manage projects within the Sponsor eTMF System and devise solutions to any challenges encountered.

• Monitor and report potential out-of-scope Records Management activities while assisting with change orders.

• Provide support and mentorship to less experienced TMF Leads.

⛳️ Requirements

• Bachelor’s degree (or its international equivalent) along with 5 years of relevant experience, or a comparable combination of education, professional training, and experience.

• Proficient knowledge of FDA and ICH/GCP regulations and guidelines.

• Capability to identify issues and escalate them in an appropriate and effective manner.

• Outstanding organizational abilities and time management skills.

• Competence in coordinating workload and achieving established deadlines.

• Proficiency in managing competing priorities efficiently.

• Familiarity with ICH-GCP, pertinent Precision SOPs, and regulatory guidance, or the capacity to be trained in and retain this knowledge.

• Strong self-motivation coupled with meticulous attention to detail.

• Ability to work independently as well as collaboratively within a team environment.

• Professional demeanor with a commitment to fulfilling obligations and maintaining positive relationships with both internal and external stakeholders.

• Effective and professional verbal and written communication skills.

• Work ethic aligned with Precision Values and Company Principles.

• Must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Comprehensive health insurance options.

• Retirement savings plan with company match.

• Opportunities for professional development and career growth.

• Flexible work arrangements and work-life balance support.

• Generous paid time off and holiday schedule.