Clinical Program Manager

About the role

The Clinical Operations Professional will join a dedicated team committed to advancing treatments for patients with RAS-addicted cancers. You will be responsible for overseeing clinical trials, adhering to SOPs and GCP guidelines, and collaborating with cross-functional teams.

Responsibilities

• Act as central contact for the Clinical Study Team(s)
• Manage and execute clinical trials within timelines and budget constraints
• Partner with cross-functional teams to manage project timelines and budgets
• Analyze data health metrics and share with stakeholders
• Drive query resolution and data listing review processes
• Conduct risk management, contingency planning, and scenario planning
• Communicate project status and issues to all key stakeholders
• Lead cross-functional Clinical Study Execution Teams (CSETs)
• Support junior team members through mentorship

Requirements

• RN or Bachelor’s/Master’s degree in biological sciences or health-related field
• 8+ years of direct Clinical Operations experience in pharmaceutical/biotech industry
• Minimum of 4 years of cross-functional study management experience
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Proven ability to manage clinical trials, including documentation and SOPs
• Experience in selecting CROs/vendors and managing external resources
• Excellent written/verbal communication and interpersonal skills
• High sense of priority and commitment to excellence
• Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint)

Qualifications

• Thrive in a collaborative team setting
• Anticipate obstacles and difficulties, and provide risk assessment and mitigation strategies
• Ability to analyze operational data and make decisions
• Multi-task, prioritize tasks, and execute on goals

Skills

• Familiarity with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
• Oncology experience, especially in early and/or late stages
• Knowledge and/or familiarity with Ex-US clinical trial operations
• Some experience mentoring junior staff

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $143,000 - $178,000 USD.