Clinical Trial Manager

Job

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).

Major Responsibilities:
• 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

Profile

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

Skills:
• 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.

Benefits

Offering:
• 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

Contact

To apply contact Stijn Otte at finance-hr@sillar-clinical.com with CV and motivation letter.

Location

Sint-Martens-Latem

Company

Sillar Clinical NV

Publication date

09.11.2020

Publication end date

08.01.2021

Sillar Clinical NV
Vacature delen via:

JOIN THE BDP COMMUNITY!

Join the community of BDP Life Sciences of Business Development professionals and Business leaders in Life Sciences & Health. Through our programmes you will connect with fellow participants, our speakers, coaches and alumni. Also connect with us online via LinkedIn.

CONTRIBUTE TO BDP

Contribute to the development of future business leaders in Life Sciences & Health by becoming a speaker, mentor or sponsor of our programmes. Contact us to discuss the possibilities via info[at]bdplifesciences.com. 

RECRUIT BD TALENT

Are you looking for a Business Development professional? Our partner PRIMER BioBusiness is specialised in the recruitment of commercial talent for the Life Sciences. Whether you need new talent, experienced professional ar an executive to lead your company, contact us to start your search.