Are you an experienced CRA ready to evolve into a lead role (stepping away from the monitoring) on international level in a dynamic, global company? Don't miss this opportunity!
As a Lead CRA you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will supervise study start-up and site management activities to verify the protection of trial subjects' rights, safety and well-being, data quality and compliance with the protocol, ICH GCP, regulatory and specific requirements on a country/regional level.
- Supervise study activities, timelines, and schedules on a country/regional level
- Coordinate start-up processes
- Review monitoring visit reports for all visit types and supervise and support Monitors in their activities
- Act as the main communication line between Monitor and Regional Lead or Project Manager
- Be a point of contact for in-house support services and vendors
- Lead project team calls on a country level
- Ensure ongoing evaluation of quality at a country/regional level, through report reviews, co-monitoring, onsite and in-house training, etc.
- Conduct site audit preparation visits, resolve or support resolution of site audit findings
- Preparation and delivering of presentations at Investigator's Meetings
- Maintain study-specific and corporate tracking systems at site and country level
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Minimum of 4 years independent on-site monitoring experience
- Participation in clinical projects as a Lead/Senior CRA
- Full working proficiency in English, Dutch and French
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, leadership, and problem-solving skills
- Valid driver's license
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17636