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
- 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 is a plus.
- 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, including meal vouchers, hospitalization and groups insurance, mobile phone, FIP-plan, etc ...
- Existing right to work in Europe required ( please read job spec in full before applying ).