Clinical Project Manager
Human Longevity, Inc. - San Diego, CA

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The Clinical Project Manager will manage and lead all aspects of a large, multicenter, multidisciplinary clinical trial including, but not limited to, protocol development to final report, staff management, regulatory management, and management of trial start-up, conduct, and close-out activities. This Manager will also lead the clinical trial project execution with minimal oversight to ensure that trial timelines, costs, and quality metrics are met; serve as primary study contact for study team and collaborator representatives in managing protocol execution; create and manage clinical trial budgets in collaboration with Head of Clinical Operations, forecast and oversee clinical supplies, and manage the financial aspect of the clinical trial to ensure accuracy, ongoing tracking, and timeliness of transactions.

Manage study milestones to ensure accurate tracking and reporting of study metrics and provide regular updates to senior management; provide study-specific direction and mentoring to study teams and collaborators; collaborate, as necessary, to maintain quality standards in compliance with regulatory requirements and adherence to Standard Operating Procedures (SOPs) and International Conference on Harmonization (ICH), Good Clinical Practices (GCPs), and local regulations; initiate ongoing process improvement; recruit and interview necessary study staff members; supervise all staff members including performance management goals and evaluation; lead regular team meetings, teleconferences and/or webinars; serve as a resource to team members for all inquiries and issue resolution; organize and ensure project training occurs, as necessary, with study staff and external collaborators; oversee ongoing service provider management (e.g. Electronic Data Capture (EDC), Central Labs, Imaging, etc.), including independent negotiation of scope of work, budgets, performance management, and issue resolution.

Qualified candidates are required to have a Master’s Degree in a related field with at least 3 years of Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) experience, 5 years of independent clinical trial management experience and at least 2 years of direct staff management experience. Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology, a broad and current knowledge of regulatory guidelines and therapeutic areas, proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met and some knowledge of statistics, is preferred. Additionally, experience in developing trial plans including creative strategies for site monitoring, risk mitigation, trial budgets, and clinical supplies management as well as a team orientation and collaboration with study team and external service providers and excellent communication, organization, negotiation, problem solving and judgment skills is essential.