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NMD Pharma A/S
Aarhus N or Copenhagen
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TMF Manager

Location: On-site in Aarhus or Copenhagen, Denmark preferred; remote candidates will be considered

Employment Type: Full-Time

Join Us in Advancing Life-Changing Therapies

At NMD Pharma, we are committed to delivering transformative therapies for people living with neuromuscular diseases. As we continue to advance our pipeline into late-stage clinical development, we are looking to expand and develop our team through the recruitment of a TMF (Trial Master File)Manager. As our TMF Manager you will play a key role in ensuring that the TMF is inspection-ready at all times, supporting robust TMF management across all clinical trials from Phase 1 to 3.

This is an exciting opportunity to work in a dynamic, and collaborative biotech environment, where your expertise will have a direct impact on our mission – to develop novel treatments to improve muscle function and quality of life for patients living with neuromuscular diseases.

Position Summary:

The TMF Manager will be responsible for designing, implementing, and maintaining robust TMF processes across the organization. In addition to internal process development and oversight, the TMF manager will provide governance and operational oversight of CROs and other vendors to ensure compliance with regulatory requirements and company standards. This is an end-to-end hands-on role with responsibility for the NMD Pharma TMF universe.

The TMF Manager will report to the Head of Clinical Operations.

Your Key Responsibilities:

  • Develop, implement, and continuously improve NMD Pharma’s internal TMF processes, SOPs, and documentation standards to ensure the NMD TMF universe meets regulatory standards.
  • Oversee the TMF maintained in NMD Pharma’s internal document management system, while ensuring alignment with CRO TMF structure and content. This requires very detailed checks at document level and actively changing document metadata.
  • Provide governance and oversight of CROs responsible for TMF management during trial execution, ensuring the TMF is complete, timely, and inspection-ready.
  • Conduct periodic TMF reviews and quality control checks, including reconciliation of the CRO TMF with internal documentation.
  • Collaborate with an internal team to coordinate and manage the transfer of the final TMF from the CRO to NMD Pharma at the end of the clinical trial, ensuring completeness, compliance, and secure archiving.
  • · Act as the TMF subject matter expert (SME), offering guidance to internal teams and external partners on TMF best practices and regulatory expectations. This includes training of relevant internal and external stakeholders.
  • Support the Quality Assurance department with any clinical trial audits and inspections, including preparation, hosting, and follow-up of TMF-related findings. Be a key liaison for NMD Pharma for any CRO inspections or audits requiring NMD Pharma support.
  • Collaborate with Clinical Operations, Regulatory, QA. Medical, and other key functions to ensure cross-functional alignment and clarity on TMF responsibilities.

What you bring:

  • Bachelor’s degree in life sciences or related field or equivalent vocational qualifications and experience.
  • At least 5 years’ experience in a TMF department who has worked closely with clinical research/GxP teams.
  • Prior experience overseeing TMF activities outsourced to CROs.
  • Demonstrable knowledge and ability to apply relevant regulations, guidelines and industry best practices related to TMF management. This includes knowledge of ALCOA+ standards, Good Documentation Practice, ICH GCP including R3 revisions, CDISC TMF Reference Model, and other regulations.
  • Must have experience developing and optimizing TMF processes, preferable in a biotech or small company setting, and be proficient in navigating electronic Trial Master File (eTMF) systems and Electronic Document Management (EDMS).
  • A strong commitment to producing high-quality work with keen attention to detail, supported by organizational, problem-solving, and communication skills.
  • Ability to work independently in a fast-paced, dynamic environment.

Why Join NMD Pharma?

At NMD Pharma, we are passionate about movement, applying our expertise to turn science into novel therapeutics that enable patients with neuromuscular diseases to live better, more independent lives. As part of our organization, you will benefit from:

  • Impact-driven work, where you will be part of a team dedicated to improving lives through innovative therapies.
  • Flexible work arrangements, with the option to choose remote work or on-site in Denmark.
  • Highly collaborative culture, working alongside a highly skilled and cross-functional team where ideas turn into action.
  • Inclusive and collaborative culture where new ideas are valued.
  • Competitive compensation package, along with structured career development pathways.

Ready to Apply?

Join us in advancing neuromuscular disease treatments. We look forward to hearing from you!

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