Data Management Leader Standards - Consultant (6 months)

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Data Management Leader Standards - Leiden (NL) or Mechelen (BE) - Consultant (6 months)

Technical Operations

Job description

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

Project Scope

We are looking for an enthusiastic and highly motivated Data Management Leader with solid Clinical Data Management (DM) expertise and standards knowledge to take responsibility of oversight activities for Galapagos’ clinical trials, supporting the Clinical Study Team (CST) through managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials.

Your mission

• Participate in CST meetings as DM representative, and closely interact with Data Science, Medical, Clinical Operations and other functional representatives
• Provide data management expertise during protocol development, including for any amendments
• Coordinate DM Contract Research Organization (CRO) Request for Proposal (RfP) selection process, create necessary Purchase Order (PO) Requests and follow up on related Goods Receipt (GR)
• Act as first point of contact for DM CRO counterparts, and ensure clinical study data management deliverables within agreed budget and timelines, and with high quality (complying with Galapagos’ processes, ICH-GCP and applicable regulations and guidelines)
• Organize relevant data management oversight meetings, and ensure minutes are documented
• Create and maintain Data Management Oversight Plan, and ensure proper execution of necessary quality control steps
• Ensure proper and timely filing of DM-specific documents and files in Trial Master File or other dedicated environment
• Actively participate in DM and Data Science team meetings
• Adhere to relevant policies and procedures, and ensure timely completion of relevant training
• Interact with Quality & Compliance to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed
• Lead or contribute to Process Improvement initiatives as required

Data Standards

• Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards and Galapagos standard extensions to CDISC
• Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both Health Authorities submissions
• Consult across different projects on conformance issues for SDTM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation

Job requirements

Who are you?

• You have a Masters’ degree in a Life Sciences field, followed by at least 7-10 years’ experience in a pharmaceutical/biotech environment (and/or relevant experience with a large CRO) in a clinical data management or closely related discipline
• You have a strong understanding of CDISC SDTM
• You are able to organize and plan multiple priorities, and to coordinate external service providersDaat
• You have a good understanding of the drug development process, applicable regulatory guidelines, and Clinical Data Management Systems
• You are a team player, and can work autonomously
• Of course, your English oral and written communication skills are excellent!

What's in it for you?

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

Get to know us

We’re in the business of changing lives. In our quest to discover, develop and deliver life-improving medicines, we go where no one has ever gone before.