Senior CRA II/ Lead Monitor

Description de l'emploi

As a Senior CRA II 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 perform and supervise study start-up, clinical monitoring 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 company/ Sponsor 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
• May need to monitor and manage sites (if applicable)
• Preparation and delivering of presentations at Investigator’s Meetings
• Maintain study-specific and corporate tracking systems at site and country level

Profil

• 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 Monitor
• 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