Clinical Study Lead - Mechelen, Leiden
Ref: MEC 228
This position can also be located in LEIDEN. Some travel will be required.
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.