Director Operational Excellence Jobs in Sutton, MA

Join Us in Shaping the Future of Clinical Research 

Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values-Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration-we create an environment where meaningful work drives meaningful change. 

At Adams Clinical, you'll find: 

• A culture of respect, transparency, and continuous improvement 
• Opportunities for professional growth and learning 
• A team dedicated to improving lives through innovation and integrity 

If you're passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we'd love to have you on our team. 

Job Role 

The Senior Manager provides site-level leadership and operational ownership of clinical operations, with direct responsibility for staff management, study execution, regulatory compliance, strategic alignment with network leadership, and ensuring high-quality trial execution that meets sponsor expectations and business objectives. The Site Director assumes the same core clinical operations responsibilities while providing broader site-wide leadership through additional support of the Clinical Science function, clinician development, cross-functional performance, and integration of clinical science with site operations in partnership with Clinical Science leadership. 

This is a highly people-focused leadership role requiring strong interpersonal skills, professional discretion and effective decision-making, and the ability to lead and develop employees at all levels of the organization. The ideal candidate is an approachable and accountable leader who builds strong relationships, communicates with clarity, and creates a culture of trust, collaboration, and high performance while maintaining clear expectations for site operations. 

Key Responsibilities: 

Study Operations and Site Performance 

• Serve as primary point of contact for day-to-day site issues; monitor study activities, enrollment, visit schedules, and site performance metrics for outpatient studies. 

• Support subject recruitment, eligibility assessments, randomization, and oversee study processes including ALCOA-compliant documentation, study trackers, investigational product handling, and ensure proper handling of participant safety events and adverse events (e.g., SAE/AESI reporting). 

• Identify operational, regulatory, or safety risks, implement mitigation strategies with senior leadership, and escalate critical issues. 

• Collaborate with Finance to review Clinical Trial Agreement (CTA) invoicing, oversee participant reimbursement processes, and support site-level budget monitoring and forecasting to ensure financial compliance and operational efficiency.  

• Review monthly P&L and present to network senior leadership monthly on prior month performance.  

• Monitor screening outcomes and screen-failure trends related to operationally preventable factors to identify recurring issues and work with site study teams and Clinical Operations leadership to implement process improvements that improve overall screening quality. 

• Exercise appropriate autonomy in day-to-day site decisions while escalating matters that require network-level alignment, senior leadership input, or clinical or medical expertise. 

Team Management and Development 

• Foster a collaborative and accountable site culture by effectively navigating employee concerns, conflict, and performance issues; advocating for staff while balancing organizational expectations; and translating leadership priorities into clear, practical expectations for the team. 

• Lead, train, and develop the Clinical Research Coordinators (CRCs), Research Assistants (RAs), and Laboratory Technicians; assign responsibilities and track staff involvement across studies.  

• Work in close collaboration with and provide support to the principal investigators and medical sub-investigators. 

• Oversee and support the recruitment, hiring, and onboarding of key site personnel (PIs, clinicians, nurses, DSMs, CRCs, RAs) and conduct regular team huddles to review study progress. 

• Collaborate with leadership across departments and sites to coordinate resources, streamline processes, and drive operational excellence. 

• Work closely with the Associate Director and Vice President of Clinical Operations along with leaders of other departments and sites to coordinate resources, streamline processes, and drive operational excellence. This position reports directly to the Associate Director of Clinical Operations. 

Facilities Oversight 

• Oversee facility and building maintenance, including office services, safety inspections, drug room security, and pest control, while ensuring efficient use of site space and adequate workspaces for staff. 

• Coordinate calibration of research equipment and support renovation, expansion, and relocation projects. 

• Manage local vendor contracts for study-related services, including laboratories and imaging. 

Study Regulatory and Quality Oversight 

• Represent the site at PSSVs, SIVs, and serve as an expert on site resources and SOPs. 

• Collaborate with regulatory teams to build and amend study source documents. 

• Monitor site activities for protocol and regulatory compliance, implement corrective actions, and support internal quality assurance checks. 

• Assist with DEA communications and audit response preparation. 

Sponsor Relations and Study Communication 

• Facilitate communication and collaboration between site teams, medical monitors, and senior leadership to address operational issues, share updates, and ensure alignment with study objectives. 

• Serve as a primary point of contact for sponsors, monitors, and other external stakeholders regarding operational and regulatory matters. 

• Generate and review site performance reports for leadership and sponsors. 

Site Director: Broader Leadership Support 

In addition to the responsibilities above, the Site Director provides broader leadership and operational ownership for the site, supporting alignment across clinical, operational, and study-related functions. This includes partnering with Clinical Science leadership and network clinical experts to promote effective training, assessment quality, therapeutic-area knowledge, appropriate staffing, and consistent study execution. 

• Support the coordination, development, and performance of clinician sub-investigators, including training needs, resource planning, and study staffing.  

• Collaborate with central clinical science leadership and participate in relevant Clinical Science meetings to support clinician development, coaching, quality, and consistency across the network. 

• Monitor clinical screening outcomes and screen-failure trends, identify recurring clinical factors or assessment findings contributing to screen failures, and work with clinicians and clinical leadership to improve assessment consistency, eligibility determination, and overall clinical screening quality. 

• Partner with network clinical experts to ensure clinicians receive appropriate training and support on study-specific clinical assessments, therapeutic area expertise, participant safety and clinical risk considerations, placebo response mitigation, and other clinical aspects of protocol execution. 
• Support the development and maintenance of consistent clinical practices across the site and network, while ensuring appropriate escalation of clinical questions or concerns to the appropriate clinical leadership. 

Qualifications 

This is a leveled role. Candidates are evaluated for the level that best matches their experience, with the minimum requirements for each level outlined below. 

• Bachelor's degree required 

• Knowledge of GCP, FDA regulations, and clinical trial protocols 

• Excellent communication, collaboration, and organizational skills 

• Strong decision-making and problem-solving skills 

• Ability to prioritize competing responsibilities in a fast-paced environment 

Senior Manager, Clinical Operations: 

• Minimum 2 years of people management experience in clinical research 

• 4+ years of clinical research experience preferred; hands-on experience as a Clinical Research Coordinator is a plus 

• Demonstrated experience directly managing and developing teams of  approximately 5+ employees, with the ability to build strong working relationships, provide coaching and constructive feedback, navigate difficult conversations, and maintain accountability while balancing employee needs with site and organizational expectations. 

• Prior research site management experience is a plus 

Site Director, Clinical Operations: 

• Minimum 4 years of people management experience in clinical research; Director-level experience strongly preferred 

• 6+ years of clinical research experience preferred; prior hands-on experience as a Clinical Research Coordinator is a plus 

• Demonstrated experience leading and developing larger, multidisciplinary teams of approximately 15+ employees, including managers, with the ability to foster accountability and collaboration, navigate complex people and operational issues, and balance employee advocacy with site performance and broader organizational objectives. 

• Site-network operational experience required 

• Clinical research financial experience is required. 

• Prior experience conducting or administering clinical research assessments is a plus (but not required), including common psychiatric and neurological assessments such as MADRS, HAM-A, HAM-D, C-SSRS, MMSE, and similar clinician- or rater-administered instruments. 

Pay: 

• Senior Manager, Clinical Operations: $120,000 - $150,000 

• Site Director, Clinical Operations: $150,000 - $180,000 

Benefits: 

• 401(k) matching 
•  Medical, Dental, & Vision insurance 
•  Employee assistance program 
•  Flexible spending account 
•  Health insurance 
•  Health savings account 
•  Life insurance 
•  Paid time off 
•  Parental leave 
•  Professional development assistance 

 Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate's or employee's qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status. 

In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the required timeframe. Adams Clinical participates in E-Verify to confirm employment eligibility.