- Communication with the sponsor and other collaborators of the project regarding data management issues.
- Production and Maintenance of key study related documentation (Data Management Plan, Data Validation Plan, EDC specifications, Data Management Report) according to standard operating procedures.
- CRF design and review determining the data collection requirements of the study through review of the protocol and other supporting documentation.
- Creation of the edit-checks included the Data Validation Plan as well as the listings and reports as agreed with the sponsor.
- Coordination of all data cleaning activities including DCF/query handling and coding management.
- Coordination of external data transfer, integration and reconciliation with the study database.
- Coordination and finalization of database lock activities in close collaboration with the sponsor, statistician and other parties.
- Development of standardization (templates and processes).
- Coaching of more junior staff
- University degree, preferably in science
- Thorough knowledge of the Data Management process
- Minimum 5 years of successful Clinical Data Management experience
- Experience in EDC systems set-up is required
- SAS programming knowledge and experience is useful
- CDISC standards knowledge is beneficial for the position
- Excellent organizational and communication skills
- Bachelor’s Degree, B.S. preferred
- Strong computer and analytical skills
- Good written and verbal communication skills
- Fluent in English
- Ability to set priorities and respect tight deadlines
- Problem solving skills, team player