Description
The Clinical Program Manager will provide leadership to a multi-functional study team in order to ensure that assigned clinical trials are executed on time, on budget, and in compliance with GCP and other applicable guidelines and regulations.Main Responsibilities:
- Partners with Clinical Operations management and Project Management to define study milestones and deliverables and executes to ensure timelines, budget and quality are met
- Directs a multi-functional study team in the day-to-day execution of clinical trials
- In collaboration with the Medical Monitor and other Clinical Operations personnel, lead the planning and execution of successful Investigator Meetings
- Supervises site monitoring, reviews monitoring reports and metrics, and participates in site auditing to ensure that these tasks are performed reliably and in compliance with applicable regulations
- Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
- Oversees biometrics vendors, partners with external service providers to develop data management plans, edit check specifications, analysis specifications, etc.
- Works closely with the Medical Monitor regarding safety reporting and interacts with CRO personnel to ensure timely and accurate delivery of data for safety monitoring committees
- Assists with the writing of clinical protocols, Investigator Brochures and annual IND reports where required
- May travel domestically and internationally (up to 30%), independently and sometimes on short notice
Requirements:
- Bachelors Degree, scientific field
- 7+ years clinical trial experience including 4+ years clinical trial management at sponsor company
- Thorough knowledge of ICH/GCP guidelines as well as 21 CFR and other applicable regulations
- Proven organizational skills with ability to manage multiple urgent priorities in parallel
- Excellent analytical, negotiation and problem-solving skills
- Broad knowledge of clinical drug development processes, industry standards, GCPs, clinical trials
To find out more about Real please visit www.realstaffing.com