Clinical Trial Manager

Meet Life Sciences is representing a growing diagnostics company based in the San Francisco Bay Area is seeking a Clinical Trial Manager to lead the execution of clinical studies supporting the development and validation of novel diagnostic products. This is a hands‑on role ideal for someone who has previously served as a trial lead within a small or mid‑sized biotech, diagnostics, or life sciences company, and is comfortable owning day‑to‑day study execution in a lean, fast‑moving environment. The Clinical Trial Manager will be responsible for driving assigned studies from startup through closeout, partnering closely with internal clinical, regulatory, quality, laboratory, data management, and external vendor/CRO teams. This individual will play a key role in ensuring studies are delivered on time, within scope, and in compliance with GCP, SOPs, regulatory requirements, and study protocols. Responsibilities: Lead day‑to‑day execution of assigned clinical studies, including startup, enrollment, maintenance, and closeout activities Serve as the primary operational point of contact for CROs, clinical sites, vendors, laboratories, and internal cross‑functional stakeholders Manage study timelines, enrollment tracking, risk logs, issue escalation, study plans, trackers, and operational dashboards Support site feasibility, selection, activation, regulatory document collection, investigator agreements, and site readiness activities Oversee vendor and CRO performance, including deliverables, timelines, budgets, invoices, purchase orders, and scope‑of‑work tracking Partner with laboratory, clinical operations, and data teams to coordinate biospecimen/sample logistics, kit management, sample tracking, and data flow Support development and review of study materials, including protocols, informed consent forms, study manuals, training materials, monitoring plans, and operational documents Ensure Trial Master File completeness, inspection readiness, and compliance with applicable regulatory and quality standards Track and escalation protocol deviations, study risks, enrollment challenges, site issues, and vendor performance concerns Collaborate with Data Management, Biostatistics, Clinical Science, Regulatory, QA, and Legal to support data review, query resolution, database lock readiness, and study reporting Participate in study team meetings, vendor meetings, site calls, and cross‑functional operational reviews; prepare agendas, minutes, and action item trackers as needed Help build scalable clinical operations processes, templates, SOPs, and best practices appropriate for a growing diagnostics organization Requirements: Bachelor’s degree in life sciences, nursing, clinical research, or related field required 5+ years of clinical operations experience within biotech, diagnostics, medical device, CRO, or life sciences environments Prior experience serving as a Clinical Trial Manager, Study Manager, or trial lead with direct ownership of clinical study execution Must have prior experience working in a small or mid‑sized biotech, diagnostics, or similarly lean life sciences company Experience managing external vendors, CROs, clinical sites, central labs, specialty labs, or sample logistics providers Strong understanding of GCP, clinical trial regulations, TMF requirements, study documentation, and inspection readiness Experience supporting observational, diagnostic, device, registry, interventional, or specimen‑based clinical studies preferred Comfortable operating in a hands‑on environment where responsibilities may span study management, vendor oversight, tracking, documentation, and process development Strong communication, organization, problem‑solving, and cross‑functional collaboration skill Ability to work onsite in the SF Bay Area 2 days per week Preferred Qualifications: Experience in diagnostics, molecular diagnostics, genomics, liquid biopsy, laboratory‑developed tests, clinical validation studies, or biomarker‑driven studies Experience coordinating biospecimen collection, sample processing, lab workflows, chain of custody, and clinical data reconciliation Prior experience supporting clinical validation or regulatory submissions for diagnostic products Experience in startup or growth‑stage company environments #J-18808-Ljbffr