Senior Manager, Clinical Operations

Senior Manager, Clinical Operations

Boston, Massachusetts, United States

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 valuesscientific rigor, operational excellence, commitment to sponsors and participants, and authentic collaborationwe 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

We are seeking a Senior Manager, Clinical Operations for a full-time role at our Boston location. The Senior Manager, Clinical Operations will oversee day-to-day site-level operations and provide leadership across study teams. This individual will be responsible for staff management, operational oversight, regulatory compliance, and ensuring high-quality trial execution that meets both sponsor expectations and business objectives.

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 both inpatient and 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 (SAE/AESI reporting).
• Identify operational, regulatory, or safety risks, implement mitigation strategies with senior leadership, and escalate critical issues.
• Work closely with the Inpatient Unit Manager and the Associate Director of Inpatient Clinical Operations to support and oversee the conduct and quality of all inpatient studies at the Watertown inpatient facility. Ensure alignment on workflows, study execution, and safety practices within the inpatient unit.
• 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.

Team Management and Development

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

Qualifications

• Bachelor's degree required.
• Minimum 2 years of people management experience in clinical research.
• 5+ years of clinical research experience preferred; hands-on experience as a Clinical Research Coordinator is a plus.
• Prior research site management experience is a plus
• 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.

Pay: $120,000 - $140,000 per year

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.