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Senior Clinical Trial Manager - (CRO) Radiopharmaceutical experienced

Aixial Group
United StatesremoteEnglish5d ago
gcpqa

Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide. Job Title: Senior Clinical Trial Manager - Radiopharmaceutical experienced Location: US, Home based Work Type: Remote, with occasional travel Job Summary: The Senior Clinical Trial Manager (CTM) provides leadership, mentoring, and technical support to the clinical monitoring team to ensure quality of deliverables and achievement of financial goals. May provide oversight and coordination of CRA(s)/CTM(s) working across regions and/or countries to ensure clinical project and site deliverables are met. Key Responsibilities: • Allocate workload and site assignments within the clinical monitoring team. • Ensure quality of the clinical monitoring deliverables within a project and maintain proper visibility of its progress by the use of tracking tools. May include the development of the Clinical Management Plan (CMP). • Ensure efficient dissemination of information across the CRA team. • Interact with the client and other functional departments related to clinical monitoring activities and deliverables. • Ensure alignment of clinical activities to budget. • Identify quality issues within the study through regular review of site communications, monitoring visit reports, etc. to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. • Support development of study materials and present at investigator or study launch meetings. • Support the identification of out-of-scope activities including the completion of clinical monitoring aspects of change orders. • Participate in business development proposals, defense meetings and proposal development. • Coaches and mentors junior CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Also sets priorities for the CTM team to complete and manage on a regional and site level. • May evaluate staff’s competency to perform visits/site contact independently via Performance...

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