- The Data Manager acts as a functional expert in the field of Clinical Research Data Management.
- He/she is responsible for ensuring the collection of correct and complete data for assigned clinical studies in an efficient way, all in compliance with applicable regulatory guidelines.
- He/she is the first point of contact for data management counterparts within External Service Providers.
In particular, you will be:
- Participating in and contributing to Clinical Study Team meetings from Data Management perspective, for the purpose of planning, set-up, conduct and close-out of Clinical Studies.
- Taking ownership of quality, timelines and budget aspects related to Data Management for your clinical studies.
- Keeping overview of planning, preparation, set-up, testing/validation, conduct, documentation and filing of Data Management processes and systems from external service/data providers, and facilitating collaboration and integration of processes and systems of multiple external service/data providers involved in a clinical study.
- Contributing to the development and implementation of the quality system for Data Management guaranteeing efficient processes and the best quality services of the Biometrics department as a whole.
- Coaching and mentoring less experienced Data Managers, and providing internal training to Bio metrics and company personnel regarding Data Management.
- The successful candidate is a Master in sciences and has at least 6 years of experience as a Data Manager in life science/pharmaceutical environment (and/or relevant experience with CRO).
- He/she is able to organize and plan multiple priorities, and to coordinate external service providers.
- Furthermore, you have good knowledge of the applicable regulatory guidelines, as well as advanced practical experience with and knowledge of Clinical Data Management System(s) and supportive software.
- Last but not least you enjoy to contribute to our Quality Management system with respect to Data Management, and to work in cross-functional teams. Of course you should have excellent communication skills in English (oral and written).