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.