Sillar Clinical is looking for an experienced Clinical Trial Manager (CTM). A CTM serves as the central contact and coordinating person within a specific trial. He/she coordinates the organization, implementation and management of clinical trials. CTM’s role will interact with other functional trial team members to ensure the quality and the effective and timely completion of the trial. The CTM assumes responsibility for the project(s).
• 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.
To apply contact Stijn Otte at firstname.lastname@example.org
with CV and motivation letter.