TMF Operations Lead

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

📋 Description

• Act as the subject matter expert for TMF and a reliable partner to study teams, offering guidance on TMF requirements, expectations, and best practices throughout the clinical trial lifecycle.

• Oversee the establishment, maintenance, quality review, and closure of electronic Trial Master Files.

• Assess TMF health, completeness, timeliness, and quality in relation to study milestones.

• Convert TMF metrics and trends into actionable insights, risks, and recommendations for study teams and leadership.

• Collaborate with Clinical Operations, external vendors, and cross-functional stakeholders to ensure adherence to expected document lists and address documentation gaps.

• Detect, investigate, and facilitate the resolution of missing, delayed, or substandard documentation.

• Raise significant TMF risks with the appropriate level of urgency and clear accountability.

• Assist in preparation for inspections, audits, and regulatory reviews.

• Contribute to the ongoing enhancement of TMF processes, work instructions, training, systems, and operational practices.

⛳️ Requirements

• Bachelor’s degree in life sciences, healthcare, or a related discipline.

• Minimum of 5 years of progressive experience in TMF operations or management within the biotechnology, pharmaceutical, or clinical research sectors.

• Extensive knowledge of ICH-GCP, FDA regulations, and relevant global guidelines.

• Strong proficiency with electronic TMF platforms.

• In-depth understanding of TMF structure, content, lifecycle management, quality controls, and inspection-readiness standards.

• Capability to evaluate TMF health, interpret metrics, identify risks, and drive issues to resolution.

• Ability to work independently, identify emerging risks, and take responsibility for outcomes.

• A collaborative, inquisitive, and improvement-focused mindset.

• Willingness to question assumptions and enhance work processes.

• Comfort with regular use of computers and office equipment, screen work, basic hand coordination, sustained focus, clear communication, and occasional mobility.

• Reasonable accommodations may be provided for individuals with disabilities.

• Experience with Veeva Vault eTMF is highly preferred.

🏝️ Benefits

• Remote work arrangement.

• Equal opportunity employer dedicated to diversity, equity, and inclusion.