Senior Clinical Project Manager – Global Clinical Operations

Location: Boston

Function: Clinical Development & Operations

Employment Type: Full-time

About the Role

We are seeking an experienced Senior Clinical Project Manager to lead the global execution of late-stage clinical trials outsourced to CROs. This is a high-impact role within Clinical Development, responsible for ensuring that studies are delivered on time, within budget, and to the highest standards of quality and compliance.

Working closely with Clinical Development Program Directors and Medical Development leaders, you will provide strategic and operational oversight across all phases of clinical trial execution from feasibility through CSR and serve as the primary operational interface between internal teams and external partners.

Key Responsibilities

• Lead the cross-functional Clinical Study Team and external partners to deliver high-quality clinical programs in alignment with timelines, budgets, and regulatory standards.
• Oversee CRO performance, endorsing project plans that define clear responsibilities, risk mitigation strategies, escalation pathways, and communication plans.
• Ensure all studies comply with GCP, ICH, and local regulatory requirements as well as internal SOPs.
• Manage study budgets and financial forecasts in close collaboration with finance and vendor partners.
• Support protocol development, country and site selection, and oversight of key study documentation (e.g., project plans, oversight manuals, communication plans).
• Provide leadership, coaching, and development for assigned Clinical Operations team members.
• Foster productive relationships with internal stakeholders and external vendors, including CROs, service providers, investigators, and affiliates.
• Drive continuous improvement by identifying opportunities to enhance processes, systems, and technology across the clinical operations function.
• Contribute to cross-functional initiatives such as SOP updates, system implementations, and change management projects.

About You

• 10+ years of clinical research experience, including at least 8 years managing global registrational trials.
• Proven success in leading CRO-managed international studies and collaborating in complex, matrixed environments.
• Strong understanding of drug development processes, FDA/EMA/ICH GCP regulations, and risk-based quality management (RBQM).
• Experience managing study budgets and working with financial tracking tools.
• Excellent leadership, organizational, and communication skills with the ability to motivate cross-functional teams.
• Demonstrated ability to manage competing priorities and maintain quality and compliance under pressure.
• Proficiency in Microsoft Office and digital tools supporting clinical operations.
• Fluent in English (written and spoken).

Why Join

This is an opportunity to play a pivotal role in advancing innovative therapies by ensuring operational excellence in global clinical development. You’ll work with passionate cross-functional teams dedicated to improving patient outcomes worldwide.