Clinical Data Manager

Clinical Data Manager, Viedoc Qmed is looking for an experienced Clinical Data Manager with strong hands-on experience in clinical database design, study build and the wider Data Management lifecycle. This is an opportunity to take genuine ownership of your studies within a leading European boutique CRO and MedTech consultancy, working closely with clients and colleagues across Europe. About Qmed For more than 20 years, Qmed Consulting has helped MedTech companies turn complex ideas into safe, approved medical devices that can improve patients’ lives. Qmed is a leading European boutique CRO and MedTech consultancy. We are headquartered in Copenhagen, with employees aprox. 40 employees located across Europe. We support both emerging innovators and established medical device manufacturers with clinical and regulatory expertise throughout the product lifecycle. Being a boutique CRO and consultancy shapes how we work. We combine specialist expertise with close client relationships, short lines of communication and a practical approach to solving complex challenges. Our employees are trusted to take responsibility, contribute their expertise and help shape how we work. Our shared approach is simple: Listen. Understand the client, the study and the challenge before deciding on the solution. Lead. Provide clear direction and use our expertise to move the work forward. Deliver. Take ownership and follow through on what we promise. Together, we work towards one purpose: enabling better health by helping strong MedTech ideas become safe and successful devices. The role We are looking for an experienced Clinical Data Manager who can take a clinical study protocol and independently translate it into an effective eCRF and database design. You will manage the process from initial design through study build, validation, user acceptance testing and go-live. You will then continue to own the Data Management activities throughout the study and through to database lock. Strong practical experience with Viedoc is highly preferred, particularly hands-on study build experience within Viedoc Designer. This is a hands-on role, but it is not purely a study-build position. You will take responsibility for your assigned studies, coordinate activities across multiple stakeholders and independently manage priorities, timelines and risks. Your responsibilities You will be responsible for:

• Designing and building eCRFs and clinical databases, with a strong focus on Viedoc Designer.
• Translating clinical study protocols and operational requirements into effective data collection structures, validation logic, edit checks and study workflows.
• Planning and coordinating database validation, user acceptance testing, release and the associated documentation.
• Managing protocol amendments, database updates and controlled changes after go-live.
• Leading ongoing data review, data cleaning and query management.
• Managing Data Management activities through to database lock.
• Acting as the primary Data Management contact for assigned studies.
• Working closely with Project Management, Clinical Operations, Biostatistics, clients and external partners.
• Managing study priorities, timelines, dependencies and risks.
• Contributing to the continued development of Qmed’s Data Management processes, templates and ways of working.

About you We imagine that you:

• Have solid experience working across the clinical Data Management lifecycle.
• Can independently translate a protocol into a well-designed eCRF and clinical database.
• Have practical experience with database build, validation, UAT, release, data cleaning and database lock.
• Are comfortable taking end-to-end responsibility for your own studies.
• Can manage several studies or activities simultaneously without losing sight of quality or deadlines.
• Communicate clearly and work effectively with both technical and non-technical stakeholders.
• Are structured, detail-oriented and comfortable making informed decisions independently.
• Take a practical and solution-oriented approach to challenges.

Hands-on experience with Viedoc Designer is highly preferred. Viedoc Study Build Certification would be a particular advantage. Experience with clinical studies involving medical devices would also be highly valuable. What you can expect from Qmed At Qmed, you will join an experienced European team where your work and judgement will have a visible impact. You can expect:

• Meaningful ownership of your studies and responsibilities.
• Varied assignments across medical device technologies and therapeutic areas.
• Close collaboration with experienced clinical, regulatory and statistical specialists.
• Direct contact with clients and external partners.
• The opportunity to influence and further develop Qmed’s Data Management capabilities.
• A working environment built around trust, professional curiosity and our commitment to Listen, Lead and Deliver.

Interested? Please send your CV and application to talent@qmed-consulting.com If you have any questions about the position or working at Qmed, you can reach out to Juan Erasmus, Data Management Team Lead, at juer@qmed-consulting.com We look forward to hearing from you.