Interim Data Management Lead

An international biopharmaceutical company is seeking a seasoned Interim Data Management Lead to provide expert oversight of clinical data activities across multiple global trials. This role sits within the Data Science function and is integral to supporting Clinical Study Teams (CSTs) throughout the entire clinical trial lifecycle—from planning and setup to close-out and data submission.

Key Details:

• Start Date: ASAP

• Contract Duration: 6 months

• Location: Leiden or Mechelen

• Languages: English required

• Commitment: Full-time preferred

• Interview Process: Streamlined for quick onboarding

Role Scope

As Interim Data Management Lead, you will:

• Lead oversight activities for assigned clinical trials, ensuring consistency, accuracy, and compliance of clinical data.

• Support Clinical Study Teams (CSTs) by managing the collection, review, and reporting of clinical trial data.

• Oversee all data-related activities throughout the planning, setup, conduct, and close-out phases of the trial.

• Act as the primary liaison for CROs, managing timelines, deliverables, and budget for data management activities.

• Ensure data is collected, cleaned, and delivered in accordance with Galapagos SOPs, ICH-GCP, and regulatory requirements.

Key Responsibilities

Clinical Data Oversight

• Represent Clinical Data Management in CST meetings and cross-functional interactions.

• Provide input during protocol development and amendments to ensure alignment with data strategy.

• Create and manage Data Management Oversight Plans, and lead data quality review processes.

• Oversee trial documentation and ensure filing in the Trial Master File (TMF).

• Coordinate audits and inspections; manage follow-up activities including CAPAs.

Vendor Management

• Lead the RfP process for CROs, oversee contracts, raise POs, and track service deliverables.

• Monitor CRO performance to ensure data quality, compliance, and on-time delivery.

Data Standards & Regulatory Support

• Guide CRF design and oversee the development of SDTM datasets in alignment with CDISC standards and Galapagos-specific extensions.

• Review and approve define.xml files, annotated CRFs, and Clinical Study Data Reviewer’s Guides.

• Resolve SDTM conformance issues and support submission-readiness for regulatory filings.

Candidate Profile

We’re looking for a clinical data expert with the following qualifications:

• 10+ years of experience in Clinical Data Management, ideally within biotech, pharma, or CRO environments.

• Strong knowledge of CDISC SDTM, ICH-GCP, and global regulatory expectations.

• Experience leading multi-trial oversight and vendor relationships.

• Excellent organizational skills with the ability to handle multiple complex trials simultaneously.

• Fluent in English, with outstanding communication and collaboration abilities.

• Comfortable operating independently while aligning with broader clinical and data science goals.

Why This Role?

• Strategic leadership opportunity in a global biotech setting.

• Direct impact on the delivery and integrity of clinical data across multiple trials.

• Work cross-functionally with high-caliber scientific and operational teams.

• Engage in submission-driven data activities with high visibility.

Interview Process

• 1st Interview – With Data Science & Clinical Operations leadership

• 2nd Interview – With QA, Regulatory, or Medical stakeholders (if applicable)

• Start Date: ASAP