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Data Manager

24/03/2020
- Mechelen

Company information
Job content

The Data Manager is a functional expert in the field of Clinical Research Data Management (DM), and as such supports 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 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 secured 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

Profile
  • You have a Masters’ degree in a Life Sciences field, followed by at least 3 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 do we offer?

We offer you a competitive remuneration package and a dynamic work environment

Contact

For further information, call Laura Schollen 04 94 04 21 32