De werving van personeel gaat iig onverminderd door nu personeel gezocht wordt voor locatie in Boston mbt fase 3 IPF, fase 2 OA en fase 2 AD in de USA.
Clinical Study Lead Phase II & III - Boston, MA
Development - Clinical Operations
Job description
The Clinical Operations team is looking for individuals to support the clinical evaluation of new drug candidates through the operational management of multinational clinical trials from phase I-III. There are multiple Clinical Study Management positions open with flexibility on title and level. All positions will have study sites in the US and/or Latin America, will require travel, and report to the Director, Clinical Development and Operations in Belgium.
The Clinical Study Manager/Senior Manager/Associate Director will be part of a team of CSLs located in Belgium that oversee Phase III studies for Idiopathic Pulmonary Fibrosis (IPF). More specifically, the candidate will oversee all the study activities in the US and LatAm.
The Clinical Study Manager/Senior Manager/Associate Director will be part of a team of CSLs located in Belgium that oversee Phases II studies for Osteoarthritis (OA). More specifically, the candidate will oversee all the study activities the US
The Clinical Study Manager/Senior Manager/Associate Director will be part of a team of CSLs located in Belgium that oversee Phases II studies in Atopic Dermatitis (AD). More specifically, the candidate will oversee all the study activities the US
Is this the right fit for you? This opportunity is for a self-motivated, organized individual, with exceptional clinical study and communications experience. Primary responsibilities include but not limited to:
Deliver (global) clinical studies 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)
Be involved in initiating and coordinating the vendor selection process
Act as primary contact person for selected vendors and ensure high quality oversight according to study plans, timelines & budget
Be key contact person for and ensure close interaction (virtual and F2F) with sites, including PIs to leverage site engagement. Build strong relationships.
Perform co-visits with CRO staff to assess performance.
Be involved in coordination of study document creation (e.g.: Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report)
Be involved in review and/or approval of 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
Ensure close interaction with cross-functional experts involved in the clinical study (Medical Monitor, PK/PD lead, DM, Stat, CMC).
Actively participate in and/or 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, as required
Requirements
The successful candidate is a Master or a PhD in life sciences and has a good understanding of drug development as well as solid experience in global clinical study management. The qualified candidate is experienced in the selection, contracting and maintaining oversight of vendors. This candidate enjoys working with cross functional and international teams and has excellent oral and written communication skills (writing and speaking). The selected candidate has strong organizational skills, the ability to work independently, and is result-driven, dynamic and able to travel. Specific therapeutic experience is a strong preference.
Current Openings
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