Head of Clinical Documentation

Job description

Does it excite you to lead a team and own the processes and systems behind our clinical trial documentation, and do you have experience with ICH-GCP and Trial Master File (TMF)? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague. Your new position As Head of Clinical Trial Documentation, you will lead a team of seven, including Clinical Trial Administrators and a System Owner. You will own both the processes and the systems that keep our trial documentation compliant and inspection-ready. You will report to Senior Director, Head of Clinical Project Management, Rikke Ottesen, and combine leadership with hands-on involvement. You join at a time when Clinical Operations is on a development journey, and you will help shape how we work as Zealand grows. As our CROs work directly in our eTMF, you will have a unique opportunity to build documentation quality into daily collaboration. We offer exciting responsibilities: Lead and develop the team, setting clear priorities and direction Own TMF and trial administration processes incl. archiving, translating ICH-GCP and regulatory expectations into practical, risk-based ways of working and SOPs Own our eTMF in Veeva Vault, including quality oversight of CROs and internal stakeholder filing, and eTMF archiving Secure TMF quality, sponsor oversight and inspection readiness Create documentation packages for partners to support trial transfers, partner audits and regulatory submissions Drive simplification and continuous improvement together with trial teams, QA, CROs and partners Your profile You are structured, collaborative and confident in engaging stakeholders across Clinical Operations and R&D. You set direction while staying close to the details, and you bring a pragmatic, risk-based mindset and a strong quality focus. You communicate clearly at all levels and have the natural authority to engage, motivate and help people grow. Extensive clinical development experience from pharma, biotech or CRO Strong practical knowledge of ICH-GCP, TMF and essential documentation, including archiving and oversight of CRO documentation quality Hands-on experience with SOP implementation and inspection readiness Experience with Veeva Vault eTMF or similar and a good understanding of GxP IT systems and use of AI Leadership experience, ideally within Clinical Operations or Clinical Process Management Your new team The Clinical Trial Documentation department is part of Clinical Operations, working closely with project teams, Quality Assurance, CROs and partners. You will join a collaborative environment built on trust, ownership and shared responsibility, with a genuine opportunity to make a visible contribution as Zealand grows. Let’s bond and be bold ​ We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.​ And we want you to help us strengthen this culture. Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.​ We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let’s bond and be bold ​ Interested in bonding with us? Then please apply no later than November 22, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying. For further information, please contact Senior Director Clinical Project Management, Rikke Ottesen,  rottesen@zealandpharma.com. We are committed to an inclusive recruitment process and welcome applications from all job applicants. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com. #LI-Onsite