Description
The Clinical Trial Manager provides operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of clinical study management (plan, initiate, conduct, close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.Main Responsibilities
- Develop operational plans including site monitoring strategies, trial budgets, site selection, and clinical supplies management
- Ensure accurate tracking and reporting of study metrics
- Provide operational input into the development of protocol feasibility questionnaires
- Perform ongoing vendor management (CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Assists the Senior Director and/or Quality group with SOPs and training requirements
- Ensures study adherence to ICH/GCP and SOPs
Skills & Experience:
- Life sciences degree or nursing equivalent
- 5+ years clinical operations experience at the CRA, CTM or CPM level
- 3-5 years clinical monitoring experience
- Oncology experience required
- Proven clinical development experience of the operational aspects of all stages of clinical studies, preferably working in a global environment and/or including monitoring or leading clinical subteams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
To find out more about Real please visit www.realstaffing.com