Clinical Data Manager

Job description

REF. 280-281

This position can also be located in LEIDEN. Some travel will be required. 

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 Biometrics and Galapagos personnel regarding Data Management.

Requirements

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).