Description
The Senior Clinical Trial Manager oversees the conduct of all clinical studies while ensuring they are completed on time, within budget and in compliance with SOP's, FDA regulations and ICH/GCP guidelines.Primary Responsibilities:
- Write clinical study protocols, assist in the design of CRFs as well as other study related documents
- Act as the primary interface with CROs and other vendors
- Execute clinical programs including development of site and vendor budgets
- Evaluate and prepare written summaries of clinical trial data
- Conduct review and source verification of clinical data and ensure timely resolution of data queries
- Manage and track required clinical site documentation
- Assist with the set-up of electronic collection of patient self-reported outcomes
- Maintain contact with investigators and other clinical staff
Education / Requirements:
- BS, MS or equivalent in life sciences, or related technical degree
- 5-10 years experience managing multi site trials, CROs and other vendors
- Substantive experience in Clinical Trial Management, specifically demonstrating application of research methodology in a clinical trial setting
- Knowledge of ePRO a plus
- Thorough knowledge of GCP/ICH requirements
To find out more about Real please visit www.realstaffing.com