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Clinical Study Lead Phase II & III Mechelen Belgium,  

Galapagos (company)


Posted on : 22 December 2017

Project Description

Ref 339

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

Locations

Mechelen, Belgium

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