Clinical Study Lead
Ref: MEC 228
You will support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management of multinational clinical studies 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).
- Initiate and coordinate the vendor selection process through RFI, RFP & BID meetings
- Be the primary contact person for selected ESP 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 Study Meetings with ESP & ad hoc internal functions
- Act as Clinical Study representative in Clinical Working Groups
- Organize and lead the Investigator Meetings
- Interact with the Quality Monitor and follow-up on audit reports & CAPA set-up
- Actively initiate and participate in Process Improvement initiatives
The successful candidate is a Master or a PhD in life sciences and at least 5 years of project management experience in (Phase I, II and/or III) clinical drug development. Experience in managing Phase I healthy volunteer studies and 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 and pro-active and able to travel.