For one of our clients, an innovative pharmaceutical company located in Leiden, we are currently looking for a "Clinical Study Lead".
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 Client 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.
- Minimal MSc and Scientific background;
- >3 years of Project Management experience
- Clinical trial management experience, including vendor oversight;
- Good communication skills;
- Strong analytical skills;
- Strong interpersonal skills and ability to adapt quickly to change;
- Organized, proficient at multitasking with good attention to detail;
- Fluency in English, knowledge of Dutch is an asset;
- Contract: Via Oxford initially 6 months, realistic long term perspective;
- A balanced salary package based on your capabilities and experience;
- Full Time position (80% is discussable);
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16914