Manager, TMF Full Time NEW

This role is responsible for leading Trial Master File (TMF) operations within a global clinical research environment, ensuring high-quality, inspection-ready documentation across clinical studies. You will manage a team of professionals, overseeing workload distribution, performance, and delivery of critical project outputs in line with regulatory and quality standards. The position plays a key role in maintaining compliance with GCP, ICH guidelines, and internal SOPs while driving operational excellence in TMF processes. You will collaborate closely with project teams, sponsors, and leadership to ensure timelines, quality, and business objectives are consistently met. This is a people leadership role combining technical TMF expertise, operational oversight, and strong stakeholder engagement in a matrix environment. You will also contribute to continuous improvement initiatives and support the development of high-performing teams in a fast-paced clinical research setting.

Accountabilities

• Lead and manage TMF team operations, including resource allocation, workload planning, and quality oversight of all deliverables.
• Ensure timely and accurate completion of TMF activities in alignment with project plans, regulatory requirements, and quality standards.
• Develop, coach, and mentor team members to enhance performance, capability, and engagement.
• Conduct performance reviews and support talent management processes including feedback, development planning, and career growth.
• Monitor team performance metrics and ensure adherence to productivity, quality, and compliance benchmarks.
• Act as a key liaison between project teams, sponsors, and internal stakeholders regarding TMF delivery and team performance.
• Support business development activities such as client interactions, presentations, and input into project bids when required.
• Oversee operational excellence initiatives, ensuring compliance with GCP, ICH guidelines, regulatory requirements, and internal SOPs.
• Contribute to resource planning, financial tracking, and project efficiency to support on-time and on-budget delivery.

Requirements

• Substantial experience in Trial Master File (TMF) management or equivalent clinical documentation coordination experience.
• Proven experience in people management, team leadership, and performance development within a clinical or CRO environment.
• Strong understanding of clinical trial processes, GCP, ICH guidelines, and regulatory compliance requirements.
• Excellent communication skills with the ability to present, influence, and collaborate effectively across global stakeholders.
• Strong organizational and multitasking abilities with attention to detail and the ability to manage competing priorities.
• Analytical and problem-solving mindset with the ability to drive operational improvements and resolve complex issues.
• Experience working in matrix, global, or virtual team environments.
• Strong client-focused approach with negotiation and stakeholder management skills.
• Degree in life sciences, pharmacy, biology, or a related health/scientific discipline preferred.

Benefits

• Competitive compensation package aligned with clinical research leadership roles.
• Opportunity to work in a global organization focused on improving patient outcomes through clinical innovation.
• Career development and leadership growth opportunities within clinical operations and TMF specialization.
• Exposure to international clinical trials and cross-functional global teams.
• Structured training and continuous professional development programs.
• Inclusive, collaborative, and purpose-driven work culture.
• Opportunities to contribute to high-impact clinical research programs supporting global healthcare advancement.

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!

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