Associate Director, Project Manager, Country Operations (Boston, MA)

Location: Boston, MA

Hybrid: 60% onsite  

We’re seeking an experienced clinical study lead in the US to join our team as Associate Director, Project Manager Country Operations (AD PMCO). In this critical role, you’ll lead the execution of high-priority clinical trials, ensuring quality, compliance, and delivery excellence from study start-up through closeout. 

This is a dynamic position ideal for professionals with a strong background in clinical trial management, local operations leadership, and cross-functional collaboration. This is more than a project management role, it’s an opportunity to shape the success of clinical trials at the local level. You’ll operate at the intersection of science, project management, and study execution in a quality-driven environment. 

Key Responsibilities

Study Execution & Oversight

• Lead the end-to-end delivery of clinical studies at the country level from feasibility and site selection to start-up, recruitment, monitoring, and closeout. 

• Ensure timely and compliant delivery of site identification, IRB submissions, activations, and patient recruitment goals. 

• Maintain oversight of monitoring activities, supporting CRAs with study-specific training and protocol execution. 

• Serve as the key point of accountability for local study quality, timelines, and milestones across assigned trials. 

Leadership & Risk Management

• Lead local study teams and ensure alignment with global plans and expectations. 

• Identify and escalate risks proactively, developing and implementing effective mitigation strategies. 

• Support country strategy implementation, driving process improvements and contributing to organizational goals. 

Cross-Functional Collaboration

• Partner with regulatory, start-up, medical affairs, legal, and global study teams to ensure cohesive study execution. 

• Oversee contract/budget negotiations, informed consent management, and ethics/authority submissions. 

• Collaborate with external stakeholders, including key opinion leaders, investigators, and patient advocacy groups, to support clinical development strategies. 

Monitoring & Quality Focus

• Ensure studies are inspection-ready at all times. 

• Coordinate accompanied site visits and oversight activities in partnership with country leadership and quality teams. 

• Drive recruitment strategy execution, ensuring enrollment goals are met while maintaining high site engagement. 

Team & Stakeholder Engagement

• Mentor local study team members (CRAs, CSAs, etc.), and potentially guide more junior PMCOs or CSMs. 

• Provide regular updates to leadership on study progress, risks, and key milestones. 

• Represent the country in global forums and regional project meetings. 

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred. 

• 5+ years of relevant experience  

• Strong project leadership experience in clinical operations, ideally in rare disease or complex therapeutic areas. 

• Proven ability to manage multiple studies across all phases of the clinical trial lifecycle. 

• Deep understanding of ICH-GCP, local regulations, and study start-up requirements. 

• Excellent cross-functional communication and stakeholder management skills. 

• Demonstrated ability to lead teams, mentor colleagues, and influence without authority. 

• Skilled in risk assessment, resource planning, and issue resolution. 

• Strong interpersonal, negotiation, and presentation skills. 

• Fluency in English (spoken and written); additional local language(s) a plus. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.