Lead TMF

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

📋 Description

• Ensure prompt and high-quality review, processing, periodic quality assessment, setup, maintenance, finalization, and archival of TMF documents.

• Develop and implement study-specific TMF Plans and project TMF Document Indexes.

• Make sure that study teams comprehend TMF expectations and relay any updates effectively.

• Organize TMF documentation, which includes TMF Plans, TMF Indexes, and documentation for Periodic Quality Reviews.

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

• Work in partnership with Project Managers and Functional Leads to sustain inspection-ready TMFs.

• Proactively foresee TMF compliance issues, recognize risks, formulate mitigation strategies, and adhere to escalation protocols.

• Track and report on TMF health, metrics, trends, risks, and instances of non-compliance.

• Act as the primary contact and Subject Matter Expert for project audits and inspections, assisting with report responses.

• Offer TMF analytics and expertise to Sponsors.

• Ensure that Periodic Quality Reviews and document assessments are finalized for assigned projects.

• Recognize TMF training requirements and facilitate or assist in team re-education initiatives.

• Oversee study close-out tasks, including final document submissions, query resolutions, eTMF exports, sponsor transfers, and acknowledgment of receipt.

• Manage projects within the Sponsor eTMF System and propose solutions for any challenges encountered.

• Monitor and report on out-of-scope Records Management activities and assist with change orders.

• Provide support and guidance to less experienced TMF Leads.

⛳️ Requirements

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

• Proficient understanding of FDA & ICH/GCP regulations and guidelines.

• Capability to identify issues and escalate them appropriately and effectively.

• Exceptional organizational skills and ability to manage time efficiently.

• Skill in coordinating workloads and meeting set deadlines.

• Competency in effectively managing competing priorities.

• Working knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, or the ability to be trained and retain this information.

• Strong self-motivation and meticulous attention to detail.

• Ability to work independently as well as collaboratively in a team setting.

• Professional demeanor with a commitment to fulfilling responsibilities.

• Strong verbal and written communication skills.

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

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Collaborative and supportive work environment.