Clinical Program Manager; CPM

Salary Range

$176,800 - $197,600 per year

Redwood City, CA - Hybrid Role

This is a unique opportunity for a Clinical Program Manager (CPM). You will be responsible for driving operational strategy across multiple trials within entire clinical programs or multiple trials across indications, and supporting program-level governance, timelines, and decision-making.

• Provide expert thought leadership at the discipline level on highly complex and business-critical assignments and begin to develop new ideas.
• Lead the Clinical Study Execution Team (CSET) meetings and ensure trial timelines are met.
• Develop trial execution strategy and timelines across study(ies).
• Participate in multiple departments or interdepartmental strategic initiatives under limited supervision as it relates to study-specific initiatives.
• May serve as a resource for others with regard to a specific study trial.
• Maintain audit/inspection readiness and oversee TMF compliance.
• Collaborate with cross-functional partners in drafting study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
• Drive consistency in processes and tools across studies.
• Contribute to the development of RFPs and participate in the selection of CROs/vendors.
• May be asked to train CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements.
• Oversee CROs, vendors, and key external partners to ensure study delivery.
• Make recommendations for the development of the study-level budget.
• Participate in the recruiting and hiring process.
• Mentor and train Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs).
• Conduct risk management, contingency, and scenario planning.
• Participate in other Clinical Operations activities as appropriate.

• BS, BA, or RN in a relevant scientific discipline.
• 8+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Expert knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• High-level cross-functional collaboration; strategic thinking across trials and functions.
• Strategic thinking across clinical trials and functions with strong program-level planning and risk management.
• Independently apply clinical trials knowledge to problems that arise during the conduct of a study.
• 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, multitask, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~25%).

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.

Clinical Program Management, Clinical Operations, Clinical Trial Execution, Program-Level Governance, Operational Strategy, Cross-Functional Leadership, Clinical Study Execution Team (CSET) Leadership, Trial Timeline Development, Strategic Planning, Risk Management and Contingency Planning, Audit and Inspection Readiness, TMF Compliance, FDA Regulations, EMA Regulations, ICH Guidelines, Good Clinical Practice (GCP), Protocol Development, ICF Development, CRF Development, Monitoring Plans, CRO and Vendor Selection, RFP Development, CRO and Vendor Oversight, Study Budget Development, Process and Tool Standardization, Training and Mentorship, Clinical Trial Management, Regulatory Compliance, Operational Data Analysis, Quality and Timeliness Management, Fiscal Responsibility, Decision-Making, eTMF, EDC, IRT, CTMS, Oncology Clinical Trials, Early-Phase Clinical Development, Late-Phase Clinical Development