Clinical Data Manager / Senior Clinical Data Manager

(Senior) Clinical Data Manager

Location: Groningen

Hours: 32–40 h/week

Hybrid Work Option Available

Are you ready to take the lead in ensuring clinical data integrity and quality? As a Clinical Data Manager / Senior Clinical Data Manager at QPS Netherlands, you’ll play a pivotal role in managing clinical trial data - all while shaping how we improve and evolve data management processes in a global CRO environment.

About QPS

QPS Netherlands B.V., located in Groningen, is part of QPS Holdings LLC - a global contract research organization (CRO) providing discovery, preclinical, and clinical services to the pharmaceutical and biotechnology industries. We support every step of the drug development journey with a strong commitment to quality and client success.

Your Role

We’re growing our Clinical Data Management team and are open to hiring at either the Clinical Data Manager or Senior Clinical Data Manager level, depending on knowledge and abilities.

As part of the team, you will ensure the quality, integrity, and compliance of clinical data in line with study protocols, SOPs, ICH guidelines, and GCP. You’ll carry out core data management activities and contribute to the ongoing maintenance of our quality systems.

Senior Clinical Data Managers take on additional responsibilities, including driving process improvements and providing training and guidance to colleagues across multiple projects.

Key Responsibilities

• Develop and review study-specific Data Management Plans, Data Validation Plans, Completion Guidelines and other DM-related documents in accordance with protocol.

• Design and validate clinical databases and CRFs in accordance with protocols, system standards, and regulatory guidelines.

• Ensure data quality through edit checks, query management, and manual data reviews.

• Support coding of medications, medical history, and adverse events in collaboration with the sponsor.

• Manage user access and ensure compliance with sponsor agreements, GCP, ICH, and QPS SOPs.

• Perform core data management tasks and contribute to audits, inspections, and SOP development as needed.

• Collaborate with Project Managers to plan, prioritize, and review data management deliverables.

• Lead study-level data management activities and make decisions on study-specific tasks.

For Senior CDMs:

• Lead study-level data management activities and make decisions on study-specific tasks.

• Train and mentor Clinical Data Managers; design task-specific training programs.

• Maintain and improve departmental SOPs and work instructions.

• Implement new processes and support the adoption of industry standards.

• Deliver internal trainings on topics such as Viedoc and ClinSpark.

What You Bring

• A University or Dutch HBO degree in a relevant scientific field

• Experience in data management within a CRO or clinical research environment is preferred

  • for CDM - Demonstrated experience in CRO, Clinical Research, or other relevant field should be at least 2 years

  • For Senior CDM - Demonstrated experience in CRO, Clinical Research, or other relevant field should be at least 5 years.

• Knowledge of GCP and ICH guidelines is preferred

• Experience with EDC systems such as Viedoc, Medidata Rave, ClinSpark, or similar is preferred

• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)

• A proactive mindset with strong analytical thinking and a detail-oriented approach, and ability to communicate technical information to a wide audience

• Fluency in English, both written and spoken is required; Dutch language skills are helpful

What We Offer

• A varied and impactful role within a dynamic, international CRO

• A hybrid work environment with flexibility to partially work from home

• A collaborative and friendly team with development and training opportunities

• A position based in our Groningen office (32–40 hours per week)

• The opportunity to influence departmental growth and innovation

Ready to Join Us?

Do you see yourself in this role? We’d love to hear from you! Please send your application (CV and short motivation letter, in English, please) to us via the Apply button above! Questions? Contact HR at hrm.nl@qps.com.

Vaccination Policy

To maintain a safe working environment, QPS offers a vaccination program that includes the Hepatitis B vaccine. For certain roles, participation is required due to the nature of the work. For this role, joining the program is voluntary, though we do strongly encourage it as part of our commitment to workplace well-being. By applying for a position at QPS, you acknowledge that you understand this policy and agree to follow it as it applies to your specific role.

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