Senior Project Manager, Clinical Operations

The Sr. Project Manager, Clinical Operations is responsible for driving portfolio-level project management and operational excellence across clinical development programs. This role partners closely with Clinical Operations leadership, Study Leads, and cross-functional teams to support the successful execution of clinical pharmacology, Phase 1, Phase 2, and Phase 3 studies.

The position combines study execution oversight with leadership of strategic initiatives designed to improve Clinical Operations processes, systems, scalability, and organizational effectiveness. The successful candidate will bring structure to complex initiatives, facilitate cross-functional collaboration, manage risks and dependencies, and help enable efficient, high-quality clinical trial execution.

Key Responsibilities

Clinical Project & Portfolio Management

• Coordinate project management activities across multiple clinical studies, ensuring alignment of timelines, milestones, risks, dependencies, and deliverables.
• Develop and maintain project plans, dashboards, status reports, risk registers, and operational metrics.
• Monitor portfolio progress, identify risks, and facilitate timely issue resolution.
• Support portfolio planning, leadership reporting, and cross-functional communication.

Cross-Functional Leadership

• Facilitate Study Execution Team (SET), governance, and operational review meetings.
• Drive accountability for decisions, action items, and follow-up activities.
• Partner with Clinical Science, Biometrics, Data Management, Regulatory Affairs, Clinical Supply, Quality Assurance, Finance, and other stakeholders to ensure successful study execution.

Strategic Initiatives & Operational Excellence

• Lead cross-functional initiatives that enhance Clinical Operations capabilities, processes, and systems.
• Manage projects such as eTMF governance, AI and automation initiatives, CDx workflows, SOP development, inspection readiness, clinical systems implementations, and process improvement programs.
• Develop standardized tools, templates, KPIs, and best practices to improve consistency, efficiency, and scalability.
• Support onboarding, training, change management, and continuous improvement efforts.

Qualifications

• Bachelor's degree in Life Sciences or a related field.
• 6-8+ years of Clinical Project Management experience and/or 8+ years in Clinical Operations, including significant biotech experience.
• Experience managing complex cross-functional clinical development programs.
• Strong understanding of clinical trial operations across early-stage, Phase 2, and Phase 3 studies.
• Demonstrated ability to lead meetings, manage timelines, mitigate risks, and influence stakeholders without direct authority.
• Experience with operational improvement initiatives, systems implementation, and change management preferred.
• Strong communication, organization, and problem-solving skills.
• Proficiency with project management tools and Microsoft Office applications.
• Experience in GCP-regulated environments and familiarity with CTMS, eTMF, and EDC systems preferred.