Description
Responsibilities:- Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget
- Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans (CMP, DMP)
- Participates in the selection of Investigators and vendors
- Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
- Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
Requirements:
- BS or Masters Degree in Nursing, life science, or related field (or equivalent experience)
- 4 or more years of project management experience with clinical studies in a sponsor setting
- 2 or more years of clinical operation experience as CRA or PM for Oncology clinical studies
- Proven track record showing clear proficiency in clinical project management skills
- Demonstrates detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
To find out more about Real please visit www.realstaffing.com