Clinical Data Management Leader - Mechelen,BE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in US, Boston.

 

We’re in the business of changing lives.  In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities.  We want to challenge the impossible.  We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.  Collaborative innovators and perseverant idealists. We need the best-in-class.  In other words, we need you: The ‘make-it-happeners’. 


The Clinical Data Management Lead 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).


What’s in it for you ?

You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

 

We are Galapagos : together we can make it happen…!