Clinical Trial Operations Lead

UpDoc, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

UpDoc, Inc. seeks a Clinical Trial Operations Lead to build and lead the operational foundation for our clinical studies.

You will translate protocols into actionable plans, design decentralized and hybrid trial models, and manage start-up, execution, and closeout with internal and external partners. You will drive recruitment, engagement, and data quality while ensuring compliance with ICH-GCP and FDA requirements.

Qualifications

• 6+ years of experience in clinical trial operations with at least 4 years in lead roles in regulated healthcare environments.
• Experience managing clinical studies end-to-end including start-up, execution, monitoring and closeout.
• Experience executing decentralized and/or hybrid trials with remote data collection and digital study technologies.

Responsibilities

• Own the operational planning and execution of UpDoc clinical studies from start-up through closeout.
• Translate protocols into detailed operational plans, timelines, milestones, responsibilities, and workflows.
• Design and operationalize decentralized and hybrid trial models including remote engagement, eConsent, ePRO/eCOA, and telehealth.
• Develop participant-centric study workflows enabling high-quality research outside traditional sites.
• Coordinate study start-up activities including site activation, IRB submissions, and onboarding.
• Manage relationships with investigators, sites, CROs, vendors, and partners.
• Drive participant recruitment, enrollment, engagement, retention, and execution per timelines.
• Establish document control to ensure audit-ready clinical trial records.
• Monitor performance, identify risks, and mitigate to keep studies on track.
• Collaborate with Clinical, Product, Engineering, Data, Quality, and Regulatory teams.
• Coordinate data collection and support data quality and readiness for analysis.
• Establish KPIs for enrollment, retention, protocol adherence, timelines, data completeness.
• Develop and review study materials including informed consent forms and manuals.
• Ensure studies comply with ICH-GCP, FDA requirements, IRB rules, and internal procedures.
• Support audits, inspections, regulatory submissions, and evidence-generation activities.
• Build scalable operations processes, templates, systems and playbooks.
• Evaluate and implement trial technologies like EDC, eConsent, ePRO/eCOA, CTMS, eTMF.

Skills

Clinical trial operations

End-to-end study management

Decentralized/hybrid trials

ICH-GCP & FDA compliance

IRB coordination

Project & program management

Communication & stakeholder mgmt

Ambiguity management

Hands-on execution

Data quality & collection

Education

Bachelor’s degree in life sciences or related field

Tools

EDC

eConsent

ePRO/eCOA

CTMS

eTMF

Telehealth

Remote monitoring

Wearables

Job description

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.