Senior Clinical Program Manager
About The Position
Revolution Medicines is seeking a Senior Clinical Program Manager to serve as a central contact for Clinical Study Teams and assist with the execution and management of clinical trials. The role leads larger, more complex trials with some oversight from senior Clinical Operations members, and leads cross-functional Clinical Study Execution Teams (CSETs) with minimal support. The Senior Clinical Program Manager provides team leadership and oversight to ensure clinical trials are managed successfully within their timelines and budgets. The position collaborates with cross-functional teams and vendors, monitors operational data and project status, manages risks and contingencies, and contributes to study documentation, SOPs, and vendor selection. The role also supports and mentors junior team members and participates in other Clinical Operations activities as appropriate.
Requirements
- RN, bachelor's degree, or master's degree in biological sciences or a health-related field.
- At least 10 years of direct Clinical Operations experience in the pharmaceutical or biotechnology industry; relevant indirect experience may also qualify.
- At least 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years managing project teams.
- Experience in oncology trials.
- Strong working knowledge of FDA regulations, ICH guidelines, and GCP.
- Demonstrated ability to start up, manage, and close out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
- Experience selecting CROs and vendors and managing external resources.
- Ability to thrive in a collaborative, fast-paced team environment and adapt while supporting innovative approaches and technologies.
- Solution-oriented approach, including anticipating obstacles and providing risk assessment and mitigation strategies.
- Excellent written and verbal communication and interpersonal skills.
- High sense of priority and commitment to excellence in executing deliverables.
- Ability to analyze operational data, maintain focus on quality, timeliness, and fiscal responsibility, make and drive decisions, multitask, prioritize, anticipate challenges, and execute goals as part of an interdisciplinary team.
- Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
- Travel may be required, approximately 25%.
Nice To Haves
- Experience with vendor systems or portals such as eTMF, EDC, IRT, or CTMS.
- Early- and/or late-stage oncology experience.
- Knowledge of or familiarity with clinical trial operations in regions outside the United States.
- Experience mentoring junior staff.
- Experience with MS Project and/or Smartsheet.
Responsibilities
- Serve as a central contact for Clinical Study Teams and assist with clinical trial execution and management.
- Adhere to Clinical Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
- Provide team leadership, guidance, and oversight for clinical trials to meet timelines and designated program budgets.
- Partner with cross-functional teams to manage and revise project timelines and budgets as needed.
- Analyze data health metrics and share them with stakeholders.
- Partner with cross-functional teams and vendors to drive query resolution and data listings review.
- Conduct risk management, contingency planning, and scenario planning.
- Communicate project status and issues, supervise work, and problem-solve to help project teams meet their goals.
- Participate in developing study-related documentation, including study protocols.
- Contribute to the selection and management of CROs and vendors, including developing requests for proposals (RFPs).
- Use available tools to track, oversee, and communicate program status to key stakeholders.
- Lead larger, more complex trials with oversight from senior Clinical Operations members.
- Lead cross-functional Clinical Study Execution Teams (CSETs) with minimal support.
- Contribute to SOP development, implementation, and training.
- Mentor junior team members.
- Participate in other Clinical Operations activities as appropriate.
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Learning and development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
