Clinical Trial Manager
About the role
Join Revolution Medicines, a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline includes RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. Current clinical development includes daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127.
Responsibilities
- Manage contract research organization (CRO) oversight and execution of clinical trials.
- Ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Engage and manage clinical CROs and other clinical study providers.
- Review and contribute to the development of study-specific documentation.
- Review and contribute to monitoring reports and other study documentation.
- Oversight of clinical trial documentation management.
- Collaborate with cross-functional teams to achieve clinical study goals.
- Follow up on assigned team action items and resolve issues.
- Negotiate and review Clinical Trial Agreements and site-specific study budgets.
- Evaluate potential clinical investigators and sites for feasibility and adherence to GCP.
- Create and implement clinical study monitoring plans.
- Conduct site visits and manage investigational product accountability.
- Prepare and track study participant enrollment projections and budgets.
- Support and mentor Clinical Research Associates (CRAs).
- Provide primary clinical operations contact for internal and external teams.
Requirements
- Bachelor's or Master's degree with a minimum of 5 years clinical operations experience in the pharmaceutical or biotech industry, preferably in oncology drug development.
- Direct experience of running early-stage clinical trials within an industry environment.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Experience in selecting and managing CROs/vendors.
- Demonstrated experience in vendor management and teamwork.
- Experience managing clinical CROs.
- Desire to collaborate in a high-energy environment.
- Excellent written and verbal communication skills.
- Ability to multi-task, prioritize, anticipate challenges, and execute goals in a team setting.
- Ability to travel (~25%).
Qualifications
- BS or MS degree.
- Minimum 5 years clinical operations experience.
- Experience in oncology drug development.
- Knowledge of FDA Regulations, ICH Guidelines, and GCPs.
- Experience in selecting and managing CROs/vendors.
- Vendor management and teamwork experience.
- Experience managing clinical CROs.
- Desire for innovation and technology deployment.
- Excellent communication skills.
- Ability to multi-task and prioritize.
- Travel ability.
Skills
- Technical expertise in managing Phase I-III clinical trials.
- Strong knowledge of clinical operations, GCP, and FDA regulatory requirements.
- Experience in oncology drug development.
- Experience in selecting and managing CROs/vendors.
- Vendor management and teamwork experience.
- Experience managing clinical CROs.
- Desire for innovation and technology deployment.
- Excellent communication skills.
- Ability to multi-task and prioritize.
- Travel ability.
Benefits
Base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $120,000 - $150,000 USD. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process, and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.