TMF Team Lead
Accountabilities: The TMF Team Lead will oversee Trial Master File operations, ensuring compliance with regulatory requirements, internal procedures, and industry best practices. This role requires strong leadership, analytical thinking, and the ability to collaborate with global teams to maintain document quality and inspection readiness.
Lead and support the delivery of TMF services across multiple clinical studies.
Ensure Trial Master Files remain inspection-ready and compliant with applicable regulations, procedures, and ALCOA principles.
Perform Records Management Compliance (RMC) oversight activities and monitor documentation quality.
Track key performance indicators and communicate performance insights to project teams and external stakeholders.
Identify operational risks, develop mitigation strategies, and support continuous improvement initiatives.
Analyze TMF data and apply insights to drive informed, data-based decisions.
Develop and maintain project-specific Quality Management Documents.
Provide guidance and expertise on TMF-related topics to project team members.
Mentor, support, and develop team members while promoting a collaborative working environment.
Collaborate with internal teams, sponsors, external partners, and quality assurance stakeholders.
Requirements:
The ideal candidate has experience in clinical research operations, strong knowledge of regulatory requirements, and the ability to manage complex documentation processes in a highly regulated environment. You should be analytical, organized, and comfortable leading teams while working with global stakeholders.
University degree preferred, ideally in Life Sciences or a related field.
3–5 years of relevant experience combining education and professional background.
Strong understanding of ICH Good Clinical Practice (GCP) guidelines.
Experience supporting regulatory inspections, including FDA, PMDA, EMA, BfArM, MHRA, or similar authorities.
Hands-on experience with document management systems and/or electronic Trial Master File (eTMF) solutions such as Veeva, Trial Interactive, or Documentum.
Experience working within regulated industries, preferably clinical research or pharmaceuticals.
Strong analytical skills with the ability to evaluate complex situations using multiple sources of information.
Excellent interpersonal and communication skills in a fast-paced, changing environment.
Ability to manage multiple priorities while maintaining accuracy and attention to detail.
Experience mentoring, training, or managing team members is highly valued.
Benefits:
Opportunity to contribute to meaningful healthcare projects that improve patient outcomes.
Global and collaborative work environment with multidisciplinary teams.
Remote work flexibility.
Supportive culture focused on inclusion, collaboration, and professional growth.
Career development opportunities and access to learning resources.
Exposure to international clinical research projects and industry-leading practices.
Opportunity to work with experienced professionals across global teams.
How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?
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