The Clinical Project Manager is responsible for participating in the planning and execution of specified clinical projects while adhering to budget, scope and timeline requirements and applicable regulations, including FDA and ICH. Responsible for the execution of clinical trial(s) from protocol design to the final clinical study report. Works under general supervision. This project Manager will be responsible for overseeing 2 ongoing or upcoming Phase I-II clinical trials within Oncology.
*Participates in the planning, implementation and management of Phase I- II clinical trials, in collaboration with Contract Research Organization (CRO) partners
*Contributes to development of RFPs and participates in selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements
*Actively involved in the execution of a clinical trial(s) from protocol design to the final clinical study report. Contributes to the development of clinical protocols and clinical study reports
*Prepares and/or coordinates review and distribution of relevant documents including but not limited to: informed consent forms, case report forms, laboratory/monitoring plans, monitoring reports
*Participates in the implementation of the operational plans for each [assigned] clinical project. Works closely with external and internal team members to ensure smooth operation and compliance with applicable regulations and FDA/EU/ ICH guidelines
*Maintains and reviews study timelines. Contributes to development of study budget(s)
*Ensures the ongoing compilation and reconciliation of the Trial Master File so that clinical trial(s) is 'audit ready' at all times. Ensures that any audit observations are addressed appropriately and in a timely manner
*May provide leadership and guidance to other clinical operation staff members
*Complies with all applicable policies regarding health, safety, and environmental policies
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