Clinical Team Lead II
1 tydzień temu
Overview
Rho is seeking a highly skilled Clinical Team Lead II to join our dedicated team of professionals. As a key member of our Clinical Operations Team, you will play a crucial role in driving project success and ensuring the delivery of high-quality clinical research.
In this role, you will independently manage and lead the clinical team on select projects, providing direction and training to CRAs assigned to those projects. You will also be responsible for overseeing all operational aspects related to the planning and management of CRA and site performance, ensuring compliance with study protocols, ICH/GCP guidelines, and local regulations.
Responsibilities
- Proactively drive project success by working closely with Project Managers to develop and implement enrollment strategies
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations
- Develop monitoring tools and plans
- Determine and drive the study start-up process, ensuring that all sites are selected and supplies provided in accordance with study start expectations
- Provide skilled review of study protocols and other study materials (e.g., CRF)
- Monitor clinical operations timelines, metrics, resourcing, budget, and activities
- Provide status updates to project management and sponsors
- Lead regular clinical team teleconferences
- Work effectively with Site Study Coordinators
- Participate in the RFP process, including internal and external business development meetings
- Review monitoring visit reports and ensure finalization is within contractual timeline
- May assist Project Managers with project management tasks as assigned
- Create and conduct training sessions, including investigator meetings, conferences, and team trainings
- Support the management and development of other CRAs
- Participate in the Clinical Operations community at Rho by leading key internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
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