Description
Roles:- Responsible for managing the direction, planning, execution, and conduct of assigned program, while ensuring compliance with FDA regulations, GCP, ICH, and Company SOPs for all clinical operational activities
- Provides operational leadership for all assigned studies and directly oversees the CRO and vendors to ensure consistency of methods, interpretation and approach
- Manages multiple external vendors to ensure clinical trials are conducted on time, within budget and in accordance with quality and GCP standards
- Assists with the writing and development of protocol synopsis, protocols and final study reports
- Assists management in hiring of clinical staff and negotiating with staffing vendors to assure staffing of project is adequate and staff performance meets the highest quality and compliance expectations
Requirements:
- Up to 25 % travel required
- Academic degree in Life Sciences or health-related field required
- 7 -10 years of experience managing clinical studies and clinical programs in a pharmaceutical or biotech environment
- 5-7 years successful experience managing external vendors and CROs
- Experience overseeing the generation and review of Data Management activities and plans including, eCRF development, User acceptance testing, including understanding of basic CDISC/CDASH and SDTM standards.
To find out more about Real please visit www.realstaffing.com