Clinical Trial Operations Lead

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 25%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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UpDoc

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🤖 Artificial Intelligence

☁️ SaaS

💰 Seed on 2024-02

Healthcare • Artificial Intelligence • SaaS

UpDoc is a clinical AI company that provides an enterprise-grade, physician-governed software platform integrated with EHRs and clinical workflows to deliver continuous, evidence-based interventions between visits for chronic disease management. The company emphasizes FDA-cleared, patient-facing large language model (LLM) capabilities, monitoring structured patient data, coordinating with care teams, and operationally embedding into health systems to improve outcomes, adherence, and reduce costs. UpDoc is backed by healthcare organizations and pharmaceutical and advocacy partners (e. g. , Mayo Clinic, Eli Lilly, American Diabetes Association).

📋 Description

• Own operational planning and execution of UpDoc clinical studies from study start-up through closeout • Translate clinical protocols into operational plans, timelines, milestones, responsibilities, and workflows • Design and operationalize decentralized and hybrid clinical trial models • Develop participant-centric workflows for research outside traditional clinical sites • Coordinate site identification and activation, IRB submissions, essential documentation, investigator onboarding, and study readiness • Manage relationships with investigators, clinical sites, CROs, research partners, technology providers, and study vendors • Drive participant recruitment, enrollment, engagement, retention, and study execution against timelines and targets • Establish complete, accurate, organized, and audit-ready clinical trial documentation • Monitor study performance, identify risks and bottlenecks, and develop mitigation plans • Partner with Clinical, Product, Engineering, Data, Quality, and Regulatory teams • Coordinate data collection, data quality, reconciliation, and readiness for analysis • Establish and track study KPIs including enrollment, retention, protocol adherence, timelines, data completeness, and operational quality • Support development and review of consent forms, participant materials, training materials, study manuals, and operational plans • Ensure compliance with protocols, ICH-GCP, FDA requirements, IRB requirements, company procedures, and quality standards • Support audits, inspections, regulatory submissions, and evidence-generation activities • Build scalable clinical trial operations processes, templates, systems, and playbooks • Evaluate and implement clinical trial technologies and decentralized trial platforms • Serve as the central operational coordination point, providing leadership visibility into study status, risks, decisions, and next steps

🎯 Requirements

• 6+ years of experience in clinical trial operations, clinical research, or clinical study management, with at least 4 years in lead roles • Experience in digital health, medical devices, SaMD, biotech, pharmaceuticals, or another regulated healthcare environment • Experience managing clinical studies end-to-end, including study start-up, execution, monitoring, and closeout • Experience executing decentralized and/or hybrid clinical trials, including participant-facing operations, remote data collection, digital study technologies, and direct-to-participant research workflows • Strong working knowledge of ICH-GCP, FDA regulations, IRB requirements, informed consent, and clinical research documentation • Experience working with clinical research sites, investigators, CROs, and external study vendors • Experience managing study timelines, budgets, enrollment targets, operational metrics, risks, and dependencies • Strong understanding of clinical data collection and data-quality processes • Excellent project and program management skills with exceptional attention to detail • Ability to create structure in an ambiguous environment and manage multiple priorities simultaneously • Strong written and verbal communication skills and ability to work with clinical, technical, scientific, and operational stakeholders • Hands-on approach and willingness to own strategic planning and detailed execution • Bachelor’s degree in life sciences, health sciences, clinical research, public health, or a related field, or equivalent relevant experience • Highly desired: experience with digital health, AI-enabled healthcare, SaMD, remote patient monitoring, connected medical devices, digital clinical trial technologies, academic medical centers, randomized controlled trials, regulatory submissions, peer-reviewed publications, early-stage clinical operations, and Product, Engineering, Data Science, or AI/ML teams • Advanced degree or clinical research certification such as CCRC or CCRP is highly desired

🏖️ Benefits

• Remote work arrangement • Opportunity to work at an early-stage startup founded by Stanford physicians • Opportunity to build clinical trial operations processes, systems, templates, and playbooks from the ground up • Opportunity to work with clinical trial technologies including EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, wearables, and connected devices

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