Director, CRA Country Operations Management

Location: Boston, Seaport 
Hybrid: 60% on site 

We are looking for a proven people leader with a strong background in clinical trial monitoring to join the local study delivery leadership team in the US to lead and manage a high-performing team of Clinical Research Associates (CRAs). As Director of Country Operations ( DCOM), you will play a critical role in supporting high-quality study delivery ​and developing CRA talent. 

This is a leadership position designed for a former CRA and has developed into a people-first manager. You’ll influence the performance and shape the careers of CRAs while reinforcing our commitment to rare disease trial execution excellence! 

Key Responsibilities 

People & Performance Management 

• Lead a dedicated team of CRAs: hiring, onboarding, coaching, performance reviews, and career development. 

• Optimize resource allocation across studies and ensure timely CRA assignments. 

• Conduct accompanied visits, monitor report reviews, and provide regular feedback to ensure quality and consistency. 

• Drive team engagement, training, and long-term talent retention. 

Clinical Delivery Oversight 

• Ensure CRA-led site activities meet recruitment goals, timelines, and quality standards. 

• Oversee inspection readiness and ensure adherence to ICH-GCP, US regulations, and internal SOPs. 

• Act as an escalation point for CRAs and support prompt resolution. 

Stakeholder  

• Collaborate with cross-functional stakeholders to achieve successful study delivery 

• Quality & Risk Management 

• Monitor KPIs and quality metrics; promptly address performance or compliance issues. 

• Contribute to country-level quality planning and continuous process improvements. 

• Participate in regional/global initiatives as delegated. 

Qualifications 

• 7+ years of experience in clinical research, with at least 3 years as a CRA on interventional Phase 2/3 trials. 

• Minimum 2–3 years of direct people management experience, leading CRAs or clinical field staff. 

• Proven track record in team leadership, performance development, and coaching. 

• Strong knowledge of ICH-GCP, clinical trial processes, and US regulatory requirements. 

• Experience with quality oversight, monitoring visit report review, and site performance evaluation. 

• Excellent interpersonal, communication, and conflict-resolution skills. 

• Fluent in English (spoken and written). 

• Ability to travel nationally. 

Preferred Qualifications 

• Advanced degree in a scientific discipline 

• Experience with Health Authority inspections and ins