Clinical Study Leader
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
- 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.