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 USto 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 influencethe performance and shape the careers of CRAs while reinforcing our commitment torare disease trial executionexcellence!

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

• Collaboratewith cross-functional stakeholders to achieve successful study delivery

• Quality & Risk Management

• Monitor KPIs and quality metrics; promptlyaddress 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 inspection readiness

• Familiarity with risk-based and central monitoring approaches

• Experience in rare disease or complex therapeutic areas

• Strong cross-functional collaboration and vendor management skills