Description
Essential Functions and Duties:- Perform the activities associated with the implementation and monitoring of clinical trials
- Assist in managing defined aspects of clinical studies at Medivation to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
- Oversee drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies
- Assist in the preparation of clinical study reports, annual reports, IND updates, etc
- Works with Medical Monitor and study team to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies
- Reviews and critiques CRF for accuracy and completeness
- Makes recommendation on appropriate study vendor(s) to study team and manages vendor(s) to achieve project goals
- Ensures that supportive study documents and plans are completed per Medivation Standard Operating Procedures or best practicies
- Contributes to wider organizational goals and/or activities as assigned
Requirements:
- BS/BA in Life Science or related discipline
- 2-5 years industry experience in drug development, including site monitoring experience
- Oncology clinical trial experience preferred
To find out more about Real please visit www.realstaffing.com