Description
The Clinical Program Manager is responsible for the execution of clinical studies to the required quality standards, on time and within budget.Primary Responsibilities:
- Manages study sites, CROs and other external vendors in accordance with corporate timelines
- Assists with establishing and tracking clinical timelines and appropriate performance metrics
- Review monitoring reports for accuracy, completeness and conformance with SOPs
- May act as a lead CRA on single or multi-center studies or as primary contact for CRO; conduct site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by CRO personnel
- Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff
- Reviews and resolves discrepancies in clinical data with clinical sites
- Tracks items related to CDAs, budget and contract completion status
- Performs QC and review of clinical study reports and other documents as requested
Skills / Experience:
- Minimum 5-7 years of experience in all operational aspects of managing clinical trials in a leadership role
- Minimum of 2 years of experience managing external vendors and CROs
- Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations
- Experience with managing all phases of a study CRO and site identification, qualification through final study report generation
- Preferred: CNS experience
Education: BS degree in Life Sciences or health-related field required
To find out more about Real please visit www.realstaffing.com