Remote Clinical Trials Lead — Decentralized & Hybrid Ops

UpDoc; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

UpDoc is seeking a Clinical Trial Operations Lead to build and lead the operational foundation for its clinical studies. This remote role prefers candidates located in the San Francisco Bay Area.

You will own planning through closeout, design hybrid trial models, and ensure high-quality research outside traditional sites. You will work with investigators, sites, CROs, and internal teams to drive recruitment, data quality, and regulatory compliance while building scalable processes and playbooks

Qualifications

• 6+ years in clinical trial operations with lead roles in healthcare.
• End-to-end management from start-up to closeout.
• Experience with decentralized or hybrid trials and remote data collection.
• Strong knowledge of ICH-GCP, FDA regulations, IRB requirements, and trial documentation.
• Experience collaborating with sites, investigators, CROs, and vendors.
• Experience managing timelines, budgets, enrollment targets, and KPIs.
• Understanding of clinical data collection and data-quality processes.
• Excellent project management and attention to detail.
• Ability to operate in ambiguity and manage multiple priorities.
• Bachelor’s degree in life sciences or equivalent experience.

Responsibilities

• Own operational planning and execution of UpDoc clinical studies from start-up to closeout.
• Translate protocols into detailed operational plans, timelines, responsibilities, and workflows.
• Design and implement decentralized and hybrid trial models with remote activities.
• Develop participant-centric workflows for high-quality research outside traditional sites.
• Coordinate start-up activities: site activation, IRB submissions, onboarding, and study readiness.
• Manage relationships with investigators, sites, CROs, and vendors.
• Drive recruitment, enrollment, engagement, retention, and execution against targets.
• Establish study documentation processes and ensure audit-ready records.
• Monitor performance, identify risks, and implement mitigation plans.
• Collaborate with Clinical, Product, Engineering, Data, Quality, and Regulatory teams.
• Coordinate data collection and partner support for data quality and readiness for analysis.
• Establish and track KPIs: enrollment, retention, protocol adherence, timelines, data completeness, quality.
• Support development of informed consent forms, participant materials, training, and manuals.
• Ensure compliance with protocols, ICH-GCP, FDA, IRB, and company procedures.
• Support audits, regulatory submissions, and evidence-generation activities.
• Build scalable operations processes, templates, systems, and playbooks.
• Evaluate and implement clinical trial technologies (EDC, eConsent, ePRO/eCOA, CTMS, eTMF, telehealth, remote monitoring).
• Serve as central operational point of coordination and provide visibility into status and risks.

Skills

Clinical trial operations

Decentralized trials

IRB & FDA familiarity

Vendor management

Project planning

Regulatory compliance

Education

Bachelor’s degree in life sciences

Tools

EDC

eConsent

ePRO/eCOA

CTMS

eTMF

Telehealth

Job description

UpDoc is seeking a Clinical Trial Operations Lead to build and lead the operational foundation for its clinical studies. This remote role prefers candidates located in the San Francisco Bay Area.

You will own planning through closeout, design hybrid trial models, and ensure high-quality research outside traditional sites. You will work with investigators, sites, CROs, and internal teams to drive recruitment, data quality, and regulatory compliance while building scalable processes and playbooks