Clinical Study Lead Phase II & III - Belgium
You will support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management of multinational clinical trials from phase I till III.
In particular, you will:
- Be responsible to deliver a clinical study from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (comply with GLPG processes, ICH-GCP and applicable regulations and guidelines).
- Initiate and coordinate the vendor selection process
- Be the primary contact person for selected vendors and ensure high quality oversight according to study plans, timelines & budget
- Coordinate study document creation (Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report,…)
- Review and/or approve study documents (Monitoring Plan, TMF plan, Data Management Plan, Safety Plan, eCRF, SAP, Mock TLFs, DTA/DTS a.o.)
- Ensure proper filing and archiving of TMF
- Internal single point of contact for assigned clinical studies, close interaction with functional experts involved in the clinical study (Medical Monitor, PK/PD lead, DM, Stat, CMC,…).
- Organize and lead cross-functional Internal Clinical Study Meetings as well as with the vendors
- Ad hoc, act as Clinical Study representative in the Clinical Development Team
- Interact with the Quality Monitor and follow-up on audit reports & CAPA set-up and resolution
- Actively initiate and participate in Process Improvement initiatives
The successful candidate is a Master or a PhD in life sciences and has a good understanding of drug development as well as a solid experience in clinical study management.
Experience in selection, contracting and maintaining overview of vendors is a plus.
He/she enjoys working in cross functional teams and has excellent oral and written communication skills especially in English (writing and speaking).
The selected candidate has strong organizational skills, is result-driven, dynamic and able to travel.