Description
The Senior Clinical Trial Manager is responsible for leading Phase I - III clinical trials in the areas of Immunology.Primary responsibilities include:
- Overall direction and leadership of Phase I - III clinical trials
- Managing a Contract Research Organization (CRO) in the conduct of clinical trials
- Fostering effective and collaborative interactions with the staff of multiple U.S. trial sites
- Preparing operational plans for clinical trial execution and managing the schedule, cost and performance (quality) to meet company timelines and budget objectives, as well as U.S. FDA standards for subject safety and data integrity
- Effective participation in project teams to ensure smooth trial enrollment and expeditious troubleshooting when operational issues arise
- Apprise senior clinical management on trial status on a regular basis
- Provide training and oversight to strive for Good Clinical Practice (GCP) compliance
- Remain current in the latest standards of clinical trial conduct
Skills / Experience:
- Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues
- Excellent written and verbal communication skills
- Bachelor's or Master's degree in a relevant scientific or health-related field
- Minimum of 5+ years experience in clinical research management including clinical monitoring, clinical trial management and managing CROs within the biotech/pharmaceutical industry
- Working knowledge of GCP and ICH guidelines and U.S. Food and Drug Administration regulations
To find out more about Real please visit www.realstaffing.com