Clinical Trial Manager
Clinical Trial Manager - Remote (United States Based)
The Clinical Trial Manager is a study manager position accountable for achieving the final clinical deliverable. The Clinical Trial Manager maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
- The clinical trial manager manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
- Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
- Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.
- Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File
- Leads regular conference call meetings with monitors and other clinical team members.
- May participate in bid defense meetings.
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
- Bachelors degree or licensed certified health care training
- 2+ years of clinical trial / study management experience
- CRO experience
- Previous experience as a field CRA preferred but not required
Sthree US is acting as an Employment Business in relation to this vacancy.