Remote 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

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.