Data Management Leader - Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in Europe, in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in the US (Boston).
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists, we need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for an enthusiastic and highly motivated Data Management Leader with solid Clinical Data Management (DM) expertise 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.
- Participate in CST meetings as DM representative, and closely interact with Biostatistics, 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 Biometrics 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
Who are you?
- You have a Masters’ degree in a Life Sciences field, followed by at least 6 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 good understanding of CDISC SDTM
- You are able to organize and plan multiple priorities, and to coordinate external service providers
- 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?
You will be part of a fast growing and amazing company. You will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!