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 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
Date Posted
10-Sept-2025
Closing Date
26-Sept-2025
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.