For one of our clients, an innovative pharmaceutical company located in Leiden, we are currently looking for a "Clinical Study Lead".
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.
Responsibilities
- 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.
Requirements
- 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;
Benefits
- 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
