Oncology Clinical Trials Lead

Regulatory Jobs; Redwood City (CA); On-site; USD 106,000 - 132,000; Full time

Job summary

Revolution Medicines is seeking an experienced Clinical Trial Manager in Clinical Operations to oversee CROs, study vendors, and regulatory compliance for oncology trials. The role requires managing trials from start-up to close-out, maintaining timelines and budgets, and ensuring high standards of GCP and FDA adherence.

You will partner with multiple functions, mentor CRAs, and contribute to TMF and safety reporting while traveling approximately 25% to sites as needed.

Qualifications

• BS or MS with 5+ years clinical operations in pharma/biotech.
• Experience running early-stage oncology trials in industry.
• Strong knowledge of FDA, ICH and GCPs governing trials.
• Experience selecting and managing CROs/vendors.
• Excellent communication and multi-tasking abilities.

Responsibilities

• Oversee CROs and trial vendors to ensure timely, compliant studies.
• Review study documents and TMF filing requirements.
• Lead site visits and monitoring activities as needed.
• Assist with safety, interim and final study reports.
• Collaborate with cross-functional teams to meet study goals.
• Negotiate CTAs and site budgets with contracts team.

Skills

FDA/GCP knowledge

Vendor management

Clinical operations

Team collaboration

Communication skills

Travel readiness

Education

BS or MS in a life science

Tools

EDC systems

Job description

Revolution Medicines is seeking an experienced Clinical Trial Manager in Clinical Operations to oversee CROs, study vendors, and regulatory compliance for oncology trials. The role requires managing trials from start-up to close-out, maintaining timelines and budgets, and ensuring high standards of GCP and FDA adherence.

You will partner with multiple functions, mentor CRAs, and contribute to TMF and safety reporting while traveling approximately 25% to sites as needed.