Description
Overview:Provides leadership to one or more study teams and provides strategic planning and organization to achieve successful study completion. The Clinical Project Manager maintains full ownership of the Affiliate portion of a study and ensures the effective and efficient delivery of region operational aspects in accordance with the study development plan and ICH/GCP standards and local regulatory requirements.
Responsibilities:
- Establishes study timelines, budget, resource, risk and quality plans
- Oversees project, protocol and site feasibility and determines site selection and patient allocation
- Manages the delivery of study activities in order to meet study plans
- Ensures monitoring reports are timely, reviewed and takes appropriate actions for follow up on site issues
- Chairs study team meetings
- Maintains tracking of study status
- Oversees the management of the local affiliate studies budget
Requirements:
- Bachelors degree in a scientific discipline
- 5 years proven experience in Clinical Research/Development
- Proven clinical development experience on the operational aspects of conducting clinical studies including CRO/vendor management, leading/working as part of a development team, and implementing clinical development plans
- Experience in Project Management including implementation of risk management plans and management of complex study budgets and resourcing plans
- International travel required
To find out more about Real please visit www.realstaffing.com