Clinical Trial Operations Lead

About UpDoc

At UpDoc, we are building the first clinically validated, physician-supervised AI agent that manages chronic diseases. We are an early-stage startup founded by Stanford physicians.

We are seeking a Clinical Trial Operations Lead to build and lead the operational foundation for UpDoc’s clinical studies as we generate the evidence needed to validate and scale our technology.

This is a remote role, with candidates preferred to be physically located in the San Francisco Bay Area.

Who You Are

You’re an experienced clinical trial operator who knows how to take a study from protocol and planning through execution, data collection, and closeout.

You have worked in digital health, medical devices, SaMD, biotech, or another regulated healthcare environment and understand what rigorous clinical research looks like. You’re comfortable working with investigators, research sites, IRBs, CROs, vendors, clinicians, and internal teams to keep complex studies moving.

You have hands-on experience executing decentralized and/or hybrid clinical trials, including remote participant engagement, virtual study activities, digital data collection, and the technologies and operational workflows required to conduct high-quality research outside traditional clinical trial sites.

What You’ll Do

• Own the operational planning and execution of UpDoc clinical studies from study start-up through closeout.

• Translate clinical protocols into detailed operational plans, timelines, milestones, responsibilities, and study workflows.

• Design and operationalize decentralized and hybrid clinical trial models, including remote participant engagement, virtual study activities, eConsent, ePRO/eCOA, remote monitoring, and other technology-enabled study activities.

• Develop participant-centric study workflows that enable high-quality clinical research to be conducted effectively outside traditional research sites.

• Coordinate study start-up activities, including site identification and activation, IRB submissions, essential documentation, investigator and study-team onboarding, and study readiness.

• Manage relationships with investigators, clinical sites, CROs, research partners, technology providers, and other study vendors.

• Drive participant recruitment, enrollment, engagement, retention, and study execution against agreed timelines and targets.

• Establish processes for study documentation and ensure clinical trial records are complete, accurate, organized, and audit-ready.

• Monitor study performance, identify operational risks and bottlenecks early, and develop mitigation plans to keep studies on track.

• Partner closely with Clinical, Product, Engineering, Data, Quality, and Regulatory teams to ensure clinical studies are aligned with product development and evidence-generation priorities.

• Coordinate study data collection and work with internal and external partners to support data quality, reconciliation, and readiness for analysis.

• Establish and track study KPIs, including enrollment, retention, protocol adherence, study performance, timelines, data completeness, and operational quality.

• Support the development and review of study materials, including informed consent forms, participant materials, training materials, study manuals, and operational plans.

• Ensure studies are conducted in accordance with applicable protocols, ICH-GCP, FDA requirements, IRB requirements, company procedures, and other relevant regulatory and quality standards.

• Support clinical study audits, inspections, regulatory submissions, and evidence-generation activities as UpDoc’s clinical program evolves.

• Build scalable clinical trial operations processes, templates, systems, and playbooks that can support a growing portfolio of studies.

• Evaluate and implement clinical trial technologies and tools where appropriate, including EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, and other decentralized trial platforms.

• Serve as the central operational point of coordination for clinical trials, providing clear visibility into study status, risks, decisions, and next steps to leadership.

What You’ll Need

• 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, including study start-up, execution, monitoring, and 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 an ambiguous environment and manage multiple priorities simultaneously.

• Strong written and verbal communication skills and the ability to work effectively with clinical, technical, scientific, and operational stakeholders.

• A 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 a related field, or equivalent relevant experience.

Highly Desired

• Experience running clinical studies for digital health, AI-enabled healthcare, Software as a Medical Device (SaMD), remote patient monitoring, or connected medical device products.

• Experience implementing and managing digital clinical trial technologies, including EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, wearables, or 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 intended to support regulatory submissions or peer-reviewed publications.

• Experience establishing clinical operations processes at an early-stage company or building a clinical trial function 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 such as CCRC, CCRP, or equivalent.