What are the responsibilities and job description for the Oncology Clinical Study Manager position at Revolution Medicines?
Job Responsibilities
As a Clinical Program Manager at Revolution Medicines, you will play a key role in the execution and management of our clinical trials. Your responsibilities will include:
• Acting as a central contact for the Clinical Study Team(s)
• Assisting with the execution and management of Revolution Medicines clinical trials
• Partnering with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed
• Conducting risk management, contingency, and scenario planning
• Supervising, communicating project status/issues, and problem solving to ensure project team goals are met
• Participating in the development of all study-related documentation, including study protocols
• Actively contributing in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs)
• Using all available tools to track, oversee, and communicate on program status to all key stakeholders
• Participating in other Clinical Operations activities as appropriate
Required Skills and Qualifications
• RN or Bachelor's or Master's degree in biological sciences or health-related field required
• 8 years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Minimum of 4 years of cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing project teams
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Proven ability to successfully start-up, manage, and close-out clinical trials, including authorizing clinical study and regulatory documentation and SOPs
• Experience in selection of CROs/vendors and management of external resources
• Excellent written/verbal communication and interpersonal skills
• High sense of priority and commitment to excellence in the successful execution of deliverables
• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus
Travel may be required (~25%)
As a Clinical Program Manager at Revolution Medicines, you will play a key role in the execution and management of our clinical trials. Your responsibilities will include:
• Acting as a central contact for the Clinical Study Team(s)
• Assisting with the execution and management of Revolution Medicines clinical trials
• Partnering with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed
• Conducting risk management, contingency, and scenario planning
• Supervising, communicating project status/issues, and problem solving to ensure project team goals are met
• Participating in the development of all study-related documentation, including study protocols
• Actively contributing in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs)
• Using all available tools to track, oversee, and communicate on program status to all key stakeholders
• Participating in other Clinical Operations activities as appropriate
Required Skills and Qualifications
• RN or Bachelor's or Master's degree in biological sciences or health-related field required
• 8 years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Minimum of 4 years of cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing project teams
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Proven ability to successfully start-up, manage, and close-out clinical trials, including authorizing clinical study and regulatory documentation and SOPs
• Experience in selection of CROs/vendors and management of external resources
• Excellent written/verbal communication and interpersonal skills
• High sense of priority and commitment to excellence in the successful execution of deliverables
• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus
Travel may be required (~25%)
