Performing selection, initiation, interim monitoring and closeout visits (remote and onsite)
Driving performance at the sites
Proactively identifying and ensuring timely resolution to study-related issues
Training, supporting and advising Investigators and site staff in study related matters
Development of recruitment plans with each site and managing and supporting enrollment
Ensure agreed monitoring KPIs are observed
Preparing and finalizing monitoring visit reports

Minimum of 4 years of CRA monitoring experience
Bachelors degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management
Excellent attention to detail
Excellent written and verbal communication skills
Excellent collaboration and interpersonal skills
Good negotiation skills
Valid driving license

Senior Clinical Research Associate

Key skills