CLINICAL PROGRAM MANAGER – CPM – (P3390)

Planet Pharma; Redwood City (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Planet Pharma is seeking a Clinical Program Manager (CPM) in Redwood City, CA to drive operational strategy across clinical programs and trials. You will govern timelines, budgets, and cross-functional decision-making while mentoring CTMs and coordinating with CROs and vendors.

The role requires 8+ years in pharma/biotech clinical operations or research, strong FDA/EMA knowledge, and the ability to manage multiple trials and budgets with a strategic, data-driven approach.

Qualifications

• BS, BA, or RN in a relevant scientific discipline.
• 8+ years of relevant experience in pharma/biotech,Clinical Ops or Clinical Research.
• Expert knowledge of FDA/EMA Regulations, ICH Guidelines, GCP.
• High-level cross-functional collaboration and program-level planning.
• Ability to analyze operational data and drive decisions.
• Travel up to ~25%.

Responsibilities

• Provide expert leadership on complex assignments and drive trial execution strategy across programs.
• Lead the Clinical Study Execution Team (CSET) meetings to ensure timelines are met.
• Develop trial execution strategies and timelines across studies.
• Oversee CROs/vendors to ensure study delivery and budget considerations.
• Mentor CTMs, CTMAs, and CTAs in clinical operations.
• Maintain audit/inspection readiness and TMF compliance.
• Collaborate on protocol and study document drafting with cross-functional partners.
• Participate in CRO/vendor RFP development and selection.

Skills

Cross-functional collaboration

Strategic planning

Risk management

FDA/EMA knowledge

Study budgeting

Vendor management

Leadership

Travel readiness

Education

BS/BA or RN in relevant discipline

Job description

Clinical Program Manager – CPM – (P3390)

Location: Redwood City, California
Category: Clinical Development and Operations
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site

Job DescriptionThe Opportunity: Clinical Program Manager (CPM)

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 support program-level governance, timelines, and decision-making.

Responsibilities

• Provide expert thought leadership at the discipline level on highly complex and business critical assignments and begins 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 department 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 development of RFPs and participates in 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 to the development of 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.

Required Skills, Experience And Education

• 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, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~25%).

Preferred Skills

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

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.