Clinical Trial Lead

Job Title: Clinical Trial Lead
Location: San Francisco, CA (Must be available to support PST hours as needed)
Travel: Limited, based on business needs
Duration: 10+ Months (Possible Extension)
 
Pay Rate: $80 - $115/hr. on W2
 
Job Summary:
This role is responsible for leading and/or supporting global clinical trials, including oversight of CROs and vendors. The position works cross-functionally to drive operational strategy, ensure high-quality execution, and support study and program objectives. The ideal candidate brings strong leadership, deep clinical operations expertise, and a proven ability to manage complex clinical programs in a regulated environment.
 
Key Duties & Responsibilities:
Clinical Trial Leadership & Execution:

• Lead and manage clinical studies in compliance with ICH/GCP, applicable local regulations, and Client SOPs
• Develop and execute clinical development operational plans to support study objectives
• Provide documented Sponsor Oversight of outsourced clinical trial activities
• Represent Clinical Operations on cross-functional project teams and in vendor/CRO governance meetings

Operational & Financial Management:

• Manage clinical study budgets, timelines, and resources with a focus on quality and operational excellence
• Support budget forecasting and maintain responsibility for invoice review and budget tracking
• Communicate study status, costs, risks, and issues to senior leadership to support timely decision-making

CRO & Vendor Oversight:

• Support selection, oversight, and performance management of CROs and external vendors
• Collaborate with CROs on site feasibility and capability assessments
• Ensure CRO and vendor activities align with operational standards and contractual expectations

Cross-Functional & External Collaboration:

• Provide Clinical Operations input into protocols, investigator brochures, regulatory documents, clinical study reports, and other key trial documentation
• Serve as Client representative to investigators, site staff, collaborators, partners, and key opinion leaders
• Develop and maintain strong internal and external stakeholder relationships

Compliance, Quality & Inspection Readiness:

• Oversee and contribute to inspection readiness activities supporting audits and regulatory inspections
• Ensure adherence to departmental and organizational SOPs and associated metrics
• Lead or participate in SOP development, review, and continuous improvement initiatives

People Leadership & Development:

• Manage and develop internal Clinical Operations staff, including hiring, training, coaching, mentoring, and performance management
• Foster a collaborative, high-performing team culture
• Act as a role model for Client’s core values

Continuous Improvement & Innovation:

• Identify operational challenges and propose innovative solutions
• Drive efficiencies and continuous improvement initiatives within Clinical Operations

 
Education:

• Bachelor’s degree required
• Bachelor’s or Master’s degree in a scientific discipline preferred
• RN or BSN highly desired (equivalent experience may be accepted)

 
Experience:

• 10+ years of pharmaceutical or clinical development experience, including CRO management
• 3+ years of people management experience (required)
• Experience supporting or leading GCP inspections and audits (highly desired)
• Strong working knowledge of ICH and GCP regulations

 
Knowledge, Skills & Abilities:

• Proven ability to solve complex problems using innovative approaches
• Excellent project management, organizational, and prioritization skills
• Strong written and verbal communication skills
• Demonstrated self-starter and collaborative team player
• Proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint