The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct, and close-out activities. This position will perform required job duties under the supervision of VP Clinical Operations to ensure trial timelines and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.
- Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trial
- Lead cross-functional study team in support of study deliverables
- Ensure accurate tracking and reporting of study metrics and timelines
- Ensure clinical trials are managed and executed following ICH GCP, regulations, the protocol, and company-specific SOPs
- Participate and respond to Quality Assurance and regulatory authority inspection audits
- Perform and manage the data review process on an ongoing basis
- Perform site visits including oversight, site qualification, initiation, monitoring, and close-out visits, as needed
- Bachelor’s, or equivalent, a degree in a scientific discipline
- Minimum of 2 years in clinical development and global trial management experience
- Recent relative experience in Oncology trials preferred
- Understanding of pharmaceutical regulatory requirements, both US and abroad
- Self-motivated, assertive, and able to function independently or as part of a team
- Highly effective communication and organizational skills
- Able to travel 25%.
- Hybrid position: 3 days a week in the office.