Description
Responsibilities:- Manages a team of Clinical Research Associates to design, plan and implement clinical research projects.
- Ensures the clinical operations team complies with all protocol, regulatory and overall clinical demands.
- Selects and oversees Contract Research Organizations (CROs) and other study vendors.
- Performs site and vendor audits as required.
- Assists with the generation of reports and documents necessary for IND through NDA submission.
Education / Experience:
- A minimum of 8 years clinical experience with at least 3 years experience in the pharmaceutical industry.
- Global Phase III experience in cardiovascular drug development strongly desirable.
- BS/RN degree or equivalent
- Experience preparing clinical trial budgets and contracts, RFPs and managing the efficient use of CROs.
- Excellent protocol writing and case report from design.
- Organizational skills necessary to implement and coordinate clinical trial activities.
To find out more about Real please visit www.realstaffing.com