Aufgaben

- Define and manage Clinical Data Management timelines on multiple studies or programs
- Coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding
- Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- Ensure appropriate study specific training is provided to assigned study teams and documented
- Ensure ongoing and timely data capture and data cleaning, including external data sources
- Provide/coordinate data management support to study teams to support timely and ongoing data review and monitoring
- Ensure study timelines are met and data quality is according to high industry standards
- Lock, transfer and archive databases
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs

Qualifikationen

- Scientific or technical education background, ideally university level
- Experience of 3 years minimum in clinical data management, with strong experience using major EDC systems and related tools and technologies
- Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements
- Good planning, organizational and communications skills
- Ability to effectively work and collaborate in a complex matrix organisation