Project Manager Clinical trials

Job Description

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;

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