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UpDoc is an early-stage startup founded by Stanford physicians, building the first clinically validated, physician-supervised AI agent for managing chronic diseases. We are seeking a Clinical Trial Operations Lead to build and lead the operational foundation for our clinical studies as we generate evidence to validate and scale our technology.
In this role, you will own the operational planning and execution of UpDoc clinical studies from start-up through closeout. You will translate clinical protocols into detailed operational plans, timelines, milestones, and workflows. You will design and operationalize decentralized and hybrid clinical trial models, including remote participant engagement, virtual study activities, eConsent, ePRO/eCOA, and remote monitoring. You will develop participant-centric study workflows that enable high-quality clinical research outside traditional research sites.
Key responsibilities include: coordinating study start-up activities (site identification, IRB submissions, investigator onboarding); managing relationships with investigators, clinical sites, CROs, and technology vendors; driving participant recruitment, enrollment, engagement, and retention; establishing processes for study documentation and audit-readiness; monitoring study performance and identifying operational risks early; partnering with Clinical, Product, Engineering, Data, Quality, and Regulatory teams; coordinating data collection and quality; establishing and tracking study KPIs; supporting development of informed consent forms and study materials; ensuring compliance with protocols, ICH-GCP, FDA requirements, and IRB standards; supporting audits and regulatory submissions; building scalable clinical trial operations processes and playbooks; evaluating and implementing clinical trial technologies (EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring); and serving as the central operational point of coordination for clinical trials.
This is a remote role with a preference for candidates physically located in the San Francisco Bay Area.
REQUIREMENTS:
- 6+ years of experience in clinical trial operations with at least 4 years in lead roles, clinical research, or clinical study management within digital health, medical devices, SaMD, biotech, pharmaceuticals, or another regulated healthcare environment
- Demonstrated experience managing clinical studies end-to-end (start-up, execution, monitoring, closeout)
- Demonstrated 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 directly 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 ambiguous environments and manage multiple priorities simultaneously
- Strong written and verbal communication skills and ability to work effectively with clinical, technical, scientific, and operational stakeholders
- Hands-on approach and willingness to own both strategic planning and detailed execution
- Bachelor's degree in life sciences, health sciences, clinical research, public health, or related field, or equivalent relevant experience
HIGHLY DESIRED:
- Experience running clinical studies for digital health, AI-enabled healthcare, SaMD, remote patient monitoring, or connected medical device products
- Experience implementing and managing digital clinical trial technologies (EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, wearables, connected devices)
- Experience designing participant-centric clinical research models that reduce reliance on traditional site-based study visits
- Experience working with academic medical centers and health-system research teams
- Experience supporting randomized controlled trials and/or studies for regulatory submissions or peer-reviewed publications
- Experience establishing clinical operations processes at early-stage companies or building clinical trial functions from the ground up
- Experience working closely with Product, Engineering, Data Science, or AI/ML teams
- Advanced degree (MPH, MS, RN, PharmD, PhD, or similar) and/or clinical research certification (CCRC, CCRP, or equivalent)
