Clinical Operations Document Manager

Clinical Operations Document Manager

Are you passionate about clinical documentation, eTMF quality, and inspection readiness? Do you want to play a key role in ensuring that our clinical trial documentation is complete, compliant, and inspection-ready at all times? Then join us as our new Clinical Operations Document Manager.

Your new role

As our new Clinical Operations Document Manager, you will be an essential part of our Global Clinical Operations organization and work closely with stakeholders across functions, geographies, and external partners as we deliver our clinical trial portfolio in an outsourced model.

Your role will be instrumental in ensuring sponsor oversight of the electronic Trial Master File (eTMF), including acting as TMF manager and drive setup, maintenance, and continuous quality oversight across clinical trials. You will take a leading role in maintaining our eTMF including performing ongoing quality checks and supporting inspection and audit activities.

We are a growing team with different levels of TMF experience and in this role, you will act as a subject matter expert, providing guidance on documentation expectations and eTMF best practices throughout the trial lifecycle. This is a role where attention to detail meets collaboration and continuous improvement.

Your future team

You will join our Clinical Operations team, who take pride in cross-functional collaboration and share the aspiration to become world-class in trial execution. You will work closely with a dedicated group of professionals who value quality, structure, and proactive problem solving in a regulated environment.

Our work environment is characterized by people empowerment, where you are expected to take ownership, take action, and make an impact. We focus on the well-being of the individual and offer flexible working conditions while prioritizing social activities that support an engaging and informal culture. You will collaborate with dedicated colleagues who value knowledge sharing, high quality, and supportive teamwork. Our culture is characterized by openness, trust, and a shared commitment to doing things right — and doing them better over time.

The position is based in Copenhagen, Denmark.

What you bring to the team

You bring solid experience working with clinical trial documentation and eTMF management and oversight in the pharmaceutical industry, and you thrive in a role with clear ownership and focus on quality. You are comfortable taking responsibility for your area of expertise and supporting others through guidance and collaboration. Experience with clinical trial documentation and VEEVA eTMF is essential.

In addition, you are skilled in:

• Governing and maintaining eTMF systems, including Expected Document Lists and quality oversight.
• Applying ICH-GCP and regulatory requirements to ensure inspection-ready documentation.
• Educating others on TMF requirements and handling.
• Working independently in a structured and proactive manner with a strong focus on quality.
• Collaborating effectively with global stakeholders and external partners.
• Communicating effortlessly in English, both verbally and in writing.

Our promise to you  

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

Applications must be received by February 22, 2026, but screening and interviews will be conducted on an ongoing basis.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.