Clinical Study Leader

Job description

Supporting the Development team in contributing to the clinical evaluation of new drug candidates through the operational management, and timely execution and delivery of clinical studies.

  • Appropriately plan allocated stud(y)/(ies) in terms of budget, resources and timelines.
  • Execute and deliver on allocated clinical stud(y)/(ies) from initial planning, setup and conduct until final reporting of results within agreed budget, timelines and with high quality.
  • Initiate and coordinate the vendor selection process.
  • Be the primary contact person for selected vendors and ensure high quality oversight of performance in accordance with agreed study plans, timelines & budget.
  • Build a sound relationship with the key vendor and site staff in charge of the execution of allocated stud(y)/(ies).
  • Develop the Clinical Study Oversight Plan and ensure that oversight activities are performed and documented accordingly.
  • Monitor budget/timelines and provide accurate forecasting
  • Monitor quality and progress of allocated stud(y)/(ies) versus agreed quality standards, budget and timelines. Flag variances to COPL and direct line management.
  • Report status of allocated stud(y)/(ies) as required.
  • Coordinate the timely creation of, review and/or approve study documents and plans.
  • Ensure proper and timely set-up, maintenance, review (i.e. Quality checks) and archiving of the Trial Master File.
  • Internal primary point of contact for assigned clinical stud(y)/(ies), close interaction with Clinical Study Team (CST) members.
  • Build sound cross-functional relationships with relevant staff from the Project Team (PT), Clinical Development Team (CDT) and with all CST members.
  • Organize and lead cross-functional Internal CST-Meetings and prepare, attend and follow-up on vendor meetings.
  • Ad hoc, act as CST representative in the CDT.
  • Interact with the Quality Monitor and follow-up on audit reports. Ensure timely creation of CAPA-plan and timely CAPA closure.
  • Comply with the company’s procedures and processes, ICH-GCP and applicable regulations and guidelines.
  • Actively initiate and participate in Process Improvement initiatives.
  • Participate in/present at team and departmental meetings
  • Participate in/present at Committee meetings (Protocol Review Committee (PRC), Management Review Committee (MRC), Development Management Committee (DMC)), as required.
  • Specific accountabilities for Early Development studies:
  •       Act as representative for Clinical Operations in the joint PT/CDT when relevant for the set-up of a study concept of an Early Development study.
  •       Take part and provide operational input in Focused Clinical Team meetings where details on the study design of an Early Development study are being discussed.
  •       Ensure a budget and timelines are allocated to a newly planned Early Development study in the project management system as required.
  • Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science
  • A minimum of 4 years of relevant experience (or equivalent) required
  • Previous experience in clinical trial management/oversight in pharmaceuticals is required
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a company car, medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Antwerp region
Contact person

Lies Deboiserie

Personal profile
Contact details
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46