A Clinical Trial Manager is responsible for planning and managing all aspects of an organization's program of clinical trials, usually for an organization undertaking pharmacological drug testing.
Clinical Trial Manager Fellow - 2.5 San Leandro, CA Job Details Full-time From $140,000 a year 11 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance Flexible schedule Qualifications Operations management Schedule management Bachelor's degree Organizational skills Clinical trial standard operating procedures Training & development Full Job Description About Fellow At Fellow, we aim to make male fertility support accessible to everyone, wherever they are, whatever the route. We want to get to the source of unanswered questions in male reproductive health and support clinicians with our research. Our mission is to create the most advanced male reproductive sciences company to support patient-clinician experiences that have been in the doldrums for decades.
Position Summary:
We are seeking an experienced Clinical Trial Manager, Central Lab Operations to lead the onboarding and operational execution of sponsor-led clinical trials and research studies that use Fellow as a central laboratory. This role translates protocols and sponsor requirements into executable laboratory plans and coordinates study intake, startup, implementation, conduct, and closeout across internal teams and external partners. The Clinical Trial Manager will serve as the primary operational lead for central-lab clinical trial activities, ensuring requirements are defined, responsibilities are clear, teams and systems are ready, risks and decisions are actively managed, and study documentation remains inspection-ready. This role also will help build scalable clinical operations infrastructure as Fellow's clinical trial portfolio grows. This role owns the clinical-trial operational framework around the laboratory. Laboratory Operations and the Laboratory Director or designee retain ownership of laboratory testing, technical procedures, result validity, staffing, and applicable CLIA and state laboratory responsibilities.
Key Responsibilities:
Own central laboratory study execution from feasibility through closeout, ensuring delivery within agreed timelines, budgets, study requirements, and applicable regulatory and quality standards. Lead study intake and operational feasibility, translating sponsor and protocol requirements into executable study plans, timelines, workflows, and resource needs. Partner with Commercial, which owns lead identification and relationship development, to evaluate prospective opportunities and transition awarded studies into execution. Serve as the primary central-lab operational point of contact for sponsors, CROs, investigator sites, vendors, and other external study partners. Lead internal cross-functional study teams, coordinating with Laboratory Operations, Laboratory Leadership, Quality, Product/Engineering, Data, Legal/Privacy, Supply Chain, Finance, and other stakeholders. Manage study timelines, deliverables, readiness, budgets, vendor performance, and key operational metrics. Lead study risk management, proactively identifying and mitigating operational risks and escalating issues that may impact study quality, timelines, budget, or delivery. Lead the development and review of study-related documentation, including laboratory manuals, study plans, collection and shipping instructions, training materials, data specifications, and study-specific procedures. Coordinate study-specific laboratory operations, including kit and specimen logistics, testing workflows, data and result requirements, storage, retention, and study closeout. Partner with Product/Engineering and Data to implement and validate study-specific system configurations, reporting, integrations, and data transfers. Ensure study teams and external partners are appropriately trained and supported throughout study execution. Maintain inspection-ready study documentation and partner with Quality and Laboratory Leadership to manage study issues, deviations, CAPAs, audits, and inspections. Provide regular, decision-ready updates to stakeholders and senior management on study progress, risks, resource needs, and key decisions. Lead study closeout and lessons learned, translating findings into scalable processes, procedures, and operational improvements.
Qualifications:
Bachelor's degree in life sciences, clinical research, laboratory science, healthcare, or a related field; equivalent relevant experience may be considered. Five or more years of clinical trial operations, central laboratory project management, clinical laboratory operations, CRO, diagnostics, or related experience, including ownership of complex cross-functional studies. Experience supporting Phase I-III clinical studies; Phase II or Phase III and central laboratory experience strongly preferred. Strong working knowledge of ICH-GCP, sponsor expectations, clinical trial documentation, risk management, and inspection readiness. Demonstrated experience translating protocols and sponsor requirements into operational plans, workflows, study documents, and measurable deliverables. Experience managing sponsors, CROs, sites, vendors, timelines, changes, deviations, sample or data reconciliation, and study closeout. Familiarity with CLIA-regulated laboratory operations and state laboratory requirements strongly preferred. Experience developing clinical operations processes, SOPs, training materials, job aids, or governance models. Excellent written and verbal communication, facilitation, organization, training, and decision-management skills. Ability to operate effectively in a growing organization, build structure where needed, and move between detailed execution and executive-level communication. Experience with LIMS, EDC, CTMS, eTMF, data transfers, or validated computerized systems is a plus. PMP, ACRP, SOCRA, or comparable project-management or clinical-research certification is a plus. This position may be hired at the Manager or Senior Manager level based on the selected candidate's experience, expertise, and demonstrated capabilities. The final title, level of ownership, and scope of responsibilities will be commensurate with the candidate's qualifications and the needs of the role.
Pay:
From $140,000.00 per year
Benefits:
Dental insurance Flexible schedule Health insurance Paid time off Vision insurance
