Description
Goal: The CTM will oversee all clinical studies performed and ensure that the studies are completed on time within budget and in compliance with FDA regulations and ICH/GCP guidelines.Roles:
- Acts as the primary interface with CROs
- Manages communications between monitors and clinical sites and CROs
- Implements and execute clinical programs, including development and administration of site and vendor budgets
- Coordinates with finance and project planning staff to ensure accurate allocation of expenses, accruals, and resources
- Ensures compliance with protocol, overall clinical objectives and FDA/ICH requirements
- Assists with the set-up of electronic collection of patient self-reported outcomes-BS,
Requirements:
- BS, MS or equivalent in life sciences, or related technical degree with 8+ years of experience
- Experience in Clinical Trial Management, specifically demonstrating application of research methodology in a clinical trial setting. Experience with ePRO a plus.
- Experience managing multi site trials, CROs and other vendors
- Thorough knowledge of GCP/ICH requirements
To find out more about Real please visit www.realstaffing.com