Senior Clinical Data Management Specialist

Do you have solid experience in clinical data management and a passion for improving the quality of life for people worldwide? Are you detail-oriented with a strong understanding of data quality and regulatory requirements?

If so, Coloplast is looking for an experienced Senior Clinical Data Management Specialist to join our team at our headquarters in Humlebæk, Denmark.

The Position
As a Senior Clinical Data Management Specialist, you will play a key role in our clinical studies. You will independently handle data management tasks and ensure that our data meets the highest quality and regulatory standards.

You will work hands-on with tasks ranging from database setup to data validation and cleaning while collaborating with cross-functional teams and external vendors to ensure projects are delivered on time. This position is ideal for a specialist who thrives in a practical role and wants to further develop in a dynamic and growth-oriented environment.

Your primary responsibilities will include:

• Setting up and maintaining databases for clinical studies (including eCRF and ePRO).
• Conducting advanced data review and quality assurance to ensure data integrity.
• Preparing and maintaining data management plans, including validation procedures.
• Coordinating with study teams, external vendors, and other stakeholders to ensure smooth data management processes.
• Monitoring data flows and ensuring timely and accurate database closure.
• Participating in the development and review of study protocols, case report forms (CRFs), and other study-related documents.

Your qualifications
We are looking for a candidate with strong technical skills and proven experience in clinical data management.

To succeed in this role, you likely have:

• A bachelor’s or master’s degree in life sciences, statistics, computer science, or a related field.
• At least 5 years of experience in clinical trial data management.
• Hands-on experience with clinical trial database systems (e.g., Medidata RAVE, Veeva Vault CDMS, Oracle Clinical, or similar).
• Knowledge of GCP (ISO14155).
• A detail-oriented and structured approach to your work.
• Strong collaboration skills and excellent communication abilities 

If you have experience and qualifications beyond the senior level, there may be an opportunity to join as a Principal Clinical Data Management Specialist.

The Department
You will join our Clinical Operations team, consisting of 20 dedicated colleagues, which is part of the Payers & Evidence organization. We plan and execute clinical studies for our Chronic Care and Wound Care portfolios. Our clinical work supports Coloplast’s strategic goals and plays a vital role in the company’s success.
You will work closely with experienced specialists and colleagues from other teams to ensure the quality and efficiency of our clinical studies.

Interested?
If you would like to know more about the position, please contact Christian Balling, Head of Data Management via dkjcba@coloplast.com. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate is found.
 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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