Clinical Program Manager (CPM)

Duties and Responsibilities

• 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.
• 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.

Requirements and Qualifications

• 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 Qualifications

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