Description
Responsibilities:- Executes clinical trials by directing a multi-functional study team.
- Ensures that timelines, budget and quality are met by partnering with Clinical Operations and Project management.
- Actively participates in CRO, site and vendor selection to ensure that trial responsiblitites are delegated.
- Provides mentorship, supervision and training to Clinical Operations Staff involved in the study.
- Leads the planning and execution of Investigator Meetings.
- Resolves issues involved with the onboarding and initiation of clinical sites as well as monitors and reports on the site initiation progress.
- Supervises site monitoring, reviews monitoring, and participates in site auditing.
- Ensures the study team is up-to-date on program status and priorities.
- Assuring that the trial is being conducted consistently across countries and sites by developing monitoring plans, manuals, and training manuals.
- Assists with the writing of clinical protocols, Investigator Brochures and annual IND reports.
Education/Experience Required:
- Bachelor's degree in a scientific field
- 7+ years of clinical trial experience (at least 4 years of independent trial Management experience with a Sponsor company
- Independent site monitoring and management experience
- Broad knowledge of clinical drug development processes
To find out more about Real please visit www.realstaffing.com