We are looking for a professional and motivated individual to join our dynamic team. This opportunity is for somebody to come in and hit the ground running, providing data management support to the clinical research team within the organisation.

The two key and main parts of this position are communication and data management.

You will be heavily involved in the co-ordination of all data management activities within the clinical projects, and also have primary responsibility for clinical data management activities within that. Some of these may include:

• Medical monitoring
• Pharmacovigilance activities
• Development and maintenance of e-CRF
• Randomization Services and stratification
• Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
• Randomization services
• Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to centers regarding quality of data and other issues)
• Data Management plan and risk-based Management Plan and other project-specific guidelines and instructions development and review
• Coordination and supervision of processing, dispatch and archiving of CRFs/queries

REQUIREMENTS

• Extensive data management experience with pharmaceutical/clinical trials
• Higher education degree, preferably in the medical domain
• Experience in a professional environment, preferably with clinical or medical data
• Experience in Clinical Data Management systems
• Good command of Dutch and English, written and spoken
• Strong organizational and time management skills
• Ability to work independently and perform multi-task activities
• Good attention to detail
• BROK certified
• Eudravigilance certification (or willing to take the course)

The communication side includes:

• Primary communication point for project teams with regard to clinical data management
• Communication line for clients for all data management aspects of clinical projects and clinical data management reporting

The terms of employment of Maastricht University are set out in the Collective Labour Agreement of Dutch Universities (CAO). Furthermore, local UM provisions also apply. For more information look at the website http://www.maastrichtuniversity.nl