Data Management Leader

Location Mechelen, Belgium
Discipline: Biotechnology
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10575
Published: about 2 months ago

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

YOUR RESPONSIBILITIES

  • 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

YOUR DETAILS:

  • 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 organise 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!

ORGANISATION:

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’

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.