Senior Manager, Clinical Operations
Boston, MA (02472) | Full-time | $105,000 – $140,000

We are representing a rapidly growing clinical research site network specializing in late-phase industry-sponsored trials for innovative treatments in psychiatric and neurological conditions. With multiple locations across the U.S., they are seeking a Senior Manager, Clinical Operations to join their Watertown, MA site.

This is a full-time, on-site leadership role overseeing day-to-day site operations, staff management, and clinical trial execution. The Senior Manager will play a pivotal role in ensuring operational excellence, regulatory compliance, and high-quality study delivery.

Key Responsibilities

Study Operations & Site Performance

• Oversee daily site operations, enrollment, visit schedules, and performance metrics for inpatient and outpatient studies.

• Support subject recruitment, randomization, documentation, IP handling, and safety reporting.

• Identify and mitigate operational, regulatory, and safety risks; escalate critical issues when needed.

• Partner with Finance on invoicing, reimbursement, budgets, and forecasting.

Team Leadership

• Manage and develop the Manager of Clinical Operations and Clinical Research Coordinators (CRCs).

• Lead hiring, onboarding, and training of key site personnel.

• Coordinate resources across departments and sites to drive efficiency and quality.

Facilities Oversight

• Manage facility maintenance, safety inspections, drug room security, and vendor contracts.

• Oversee calibration of equipment and support renovation or expansion projects.

Regulatory & Quality Oversight

• Represent the site at PSSVs, SIVs, and sponsor meetings.

• Collaborate on source document development and protocol compliance.

• Implement corrective actions and support audits and DEA communications.

Sponsor & Stakeholder Engagement

• Serve as a key point of contact for sponsors, monitors, and stakeholders.

• Provide performance updates and ensure alignment with study objectives.

Qualifications

• Bachelor’s degree required.

• 2+ years of people management experience in clinical research.

• 3+ years of clinical research experience preferred; CRC experience a plus.

• Strong knowledge of GCP, FDA regulations, and trial protocols.

• Excellent communication, leadership, and organizational skills.

• Ability to thrive in a fast-paced environment with competing priorities.

Why Join?

• Opportunity to shape and lead high-performing clinical research teams.

• Play a critical role in advancing innovative treatments for psychiatric and neurological conditions.

• Competitive salary ($105,000 – $140,000) with comprehensive benefits including medical, dental, vision, 401(k) + match, PTO, and parental leave.

• Collaborative environment with strong growth and professional development opportunities.