Clinical Trial Manager
• Creates project plans, coordinates project activities and schedules status, budget, training and deadline meetings.
• Develops, reviews and approves protocols, CRF’s and newsletters.
• Develops all monitoring plans and trial instructional material (trial operations manuals).
• Provides monthly status reports in the Management Meetings, including: regulatory/EC document collection, site start up status, enrolment status, monitoring visit reports, site drug inventories, serious adverse events (SAEs); number of CRFs retrieved, etc...
• Reviews and approves Monitoring Visit Reports.
• Manages all queries from the Sponsor.
• Provides guidance and mentoring to the trial team.
• Establishes and guards trial timelines
• Reviews & signs timesheets and expense reports of in-house staff.
• Assists the Quality Department in writing/reviewing SOPs
• Assists the CRA in the Site Initiation Visits
• Performs accompanied Site Monitoring Visits.
• Performs regular internal audits of the TMF to ensure that all essential documents are filed in compliance with GCP and regulatory requirements and SOP
For initial consideration, a candidate must meet the following criteria:
• Have experience working as a Clinical Trial Manager.
• A master degree in a medical, health or science related area
• Fully proficient in reading, writing and speaking Dutch, French and English.
• Must be a resident of Belgium
Considered as an asset:
• Experience in vaccines
• Experience in medical devices
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail.
• Coordination and planning of budgets, people and time management.
• Problem solving at a strategic level, working with others to reach a solution.
• Careful planning to achieve accurate and timely results.
• Open and clear communicator.
• Excellent organizational, diplomacy and team leader skills.
• Be IT-minded and proficient in using cloud solutions and MS Office applications.
• Ability to work home-based on regular basis (be at the office 2d/week)
• Competitive salary (company car, health insurance, meal vouchers, … )
• Working in a small company in full expansion means that your contribution to the growth of company will be appreciated