Clinical Trial Manager

Company Overview Our client is a late-stage biotechnology company focused on advancing innovative therapies for patients with high unmet medical needs. As the organization continues to grow and expand its clinical pipeline, they are seeking a Clinical Trial Manager to join their Clinical Operations team in San Diego. Position Summary The Clinical Trial Manager will be responsible for overseeing the operational execution and management of clinical studies from study start-up through closeout. This individual will play a key role in ensuring trials are conducted efficiently, within timelines and budget, and in compliance with regulatory guidelines and company SOPs. The ideal candidate thrives in a fast-paced biotech environment and brings strong cross‑functional collaboration and vendor management experience. Key Responsibilities Manage day-to-day clinical trial operations for assigned studies Oversee CROs, vendors, and study-related external partners to ensure high-quality deliverables Track study timelines, milestones, enrollment, and overall study performance Lead study start-up activities, including site selection, activation, and initiation Ensure compliance with ICH-GCP, FDA regulations, and internal SOPs Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, Biostatistics, and Medical Affairs teams Identify operational risks and proactively implement mitigation strategies Support development and review of study documents, including protocols, informed consent forms, monitoring plans, and study manuals Participate in investigator meetings, vendor meetings, and internal study team discussions Assist with budget tracking, forecasting, and invoice review activities Qualifications Bachelor’s degree in Life Sciences or related field required 5+ years of clinical operations experience within biotech or pharmaceutical industry Prior experience independently managing clinical trials required Strong knowledge of ICH-GCP guidelines and clinical trial regulations Experience managing CROs and external vendors Excellent organizational, communication, and project management skills Ability to work effectively in a collaborative and fast-paced environment Experience in late-stage or pivotal studies preferred #J-18808-Ljbffr