TMF Lead/Senior TMF Lead

About This Opportunity

We are representing a confidential clinical research organization seeking an experienced TMF Lead/Senior TMF Lead to join their remote team. This position is open to candidates located in Hungary, Romania, Serbia, or Slovakia.

In this role, you will oversee the creation, management, and delivery of electronic Trial Master Files (eTMF) in full compliance with Good Clinical Practice (GCP), ICH E6 Guidelines, and relevant regulatory requirements including 21 CFR Parts 312 and 314 and EMA Clinical Trials Directives.

Responsibilities

• Create and execute study TMF Plans and project TMF Document Indexes, ensuring the entire study team understands expectations and project-specific aspects
• Attend and contribute to project kick-off meetings, internal/external meetings, and ad hoc sessions to communicate eTMF status, gaps, and escalations
• Maintain eTMF systems with current information related to countries, sites, contacts, and applicable TMF document requirements
• Collaborate with Project Managers and Functional Leads to ensure timely, high-quality TMF documentation submission and maintain inspection-ready status
• Monitor and report on TMF Health to internal teams and sponsors, identifying trends, risks, and overall status
• Serve as Subject Matter Expert for project audits and inspections, supporting report responses and escalating significant risks as needed
• Perform Quarterly Completeness/Compliance checks for assigned projects with proper documentation
• Manage study close-out activities including timelines, document processing, query resolution, eTMF exports, and sponsor transfers
• Provide training and education to clinical teams on good documentation practices and TMF requirements
• Support process development and improvement initiatives within Records Management; mentor junior team members
• Serve as a System Superuser for assigned activities and tickets

What We're Looking For

Required Experience and Education:

• 4-year college degree or equivalent combination of education and experience, ideally in business, scientific, or healthcare discipline
• At least 3-4 years of experience with TMF and/or eTMF, with a minimum of 1+ year working as a TMF Lead
• Professional-level English proficiency (written and verbal)
• Established experience with Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
• Experience with Veeva Vault for document processing is highly desirable

Skills and Competencies:

• Working knowledge of ICH-GCP and relevant regulatory guidance
• Strong interpersonal and communication skills, both verbal and written
• Ability to manage competing priorities effectively in a fast-paced environment
• Detail-oriented with capability to work independently and collaboratively
• Strong self-motivation and professionalism
• Ability to identify when escalations are necessary and execute resolutions with leadership support

How We Work With You

Our talent team at Get A Job.ai partners with leading organizations in clinical research to identify exceptional candidates. When you apply through our platform, a dedicated recruiter will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration. Please note that all applications must come through Get A Job.ai—do not contact the client directly.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Opportunity: Get A Job.ai is committed to inclusive hiring practices and evaluates all qualified applicants without regard to race, color, religion, sex, national origin, disability status, or any other protected characteristic.