16922 Clinical Team Lead
・Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business
・Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations.
・Sets the project related clinical operations objectives and strategy in collaboration with the Core Team.
・Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list.
・Requests, manages and tracks clinical project resource needs.
・Provides clinical operations input into cross functional project plans.
・Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team.
・Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects.
・Writes the prototype informed consent form.
・Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries.
・Assists in the design of the CRF, EDC or equivalent.
・Owns the development of project-specific site and monitoring tools.
・Owns the development of training materials and training specific to the clinical operations team.
・Develops and presents the clinical operations training materials for Investigator Meetings.
・Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans.
・Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope.
・Responsible for managing the clinical operations timelines as agreed with the client.
・Participate in internal project review meetings and provides clinical operations updates to the project management team.