Clinical Trial Operations Lead

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the operational planning and execution of UpDoc clinical studies from initiation to completion.

• Convert clinical protocols into actionable operational plans, timelines, milestones, responsibilities, and workflows.

• Create and implement decentralized and hybrid clinical trial models.

• Develop participant-focused workflows for research conducted outside conventional clinical sites.

• Oversee site identification and activation, IRB submissions, essential documentation, investigator onboarding, and study readiness.

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

• Propel participant recruitment, enrollment, engagement, retention, and study execution in accordance with timelines and targets.

• Establish thorough, precise, organized, and audit-ready clinical trial documentation.

• Monitor study performance, identify potential risks and bottlenecks, and formulate mitigation plans.

• Collaborate with Clinical, Product, Engineering, Data, Quality, and Regulatory teams.

• Coordinate data collection, data quality assurance, reconciliation, and readiness for analysis.

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

• Assist in the development and review of consent forms, participant materials, training materials, study manuals, and operational plans.

• Ensure adherence to protocols, ICH-GCP, FDA regulations, IRB requirements, company procedures, and quality standards.

• Support audits, inspections, regulatory submissions, and evidence-generation activities.

• Develop scalable clinical trial operations processes, templates, systems, and playbooks.

• Assess and implement clinical trial technologies and platforms for decentralized trials.

• Act as the central operational coordination point, offering leadership insights into study status, risks, decisions, and next steps.

⛳️ Requirements

• Minimum of 6 years of experience in clinical trial operations, clinical research, or clinical study management, with at least 4 years in leadership positions.

• Background in digital health, medical devices, SaMD, biotech, pharmaceuticals, or another regulated healthcare field.

• Proven experience managing clinical studies from start to finish, including initiation, execution, monitoring, and closure.

• Experience in executing decentralized and/or hybrid clinical trials, incorporating participant-facing operations, remote data collection, digital study technologies, and direct-to-participant research workflows.

• Solid understanding of ICH-GCP, FDA regulations, IRB requirements, informed consent processes, and clinical research documentation.

• Experience collaborating with clinical research sites, investigators, CROs, and external study vendors.

• Proven track record in managing study timelines, budgets, enrollment goals, operational metrics, risks, and interdependencies.

• Strong comprehension of clinical data collection and data quality assurance processes.

• Exceptional project and program management skills with a keen focus on detail.

• Capability to establish order in ambiguous settings and manage multiple priorities effectively.

• Strong written and verbal communication abilities, capable of engaging with clinical, technical, scientific, and operational stakeholders.

• Proactive approach and readiness to take charge of strategic planning and detailed execution.

• Bachelor’s degree in life sciences, health sciences, clinical research, public health, or a related discipline, or equivalent relevant experience.

• Highly preferred: experience in 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 collaboration with Product, Engineering, Data Science, or AI/ML teams.

• Advanced degree or clinical research certification such as CCRC or CCRP is highly desirable.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunity to work at an early-stage startup founded by Stanford physicians.

• Chance to create clinical trial operations processes, systems, templates, and playbooks from the ground up.

• Opportunity to engage with clinical trial technologies including EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring, wearables, and connected devices.