Senior Manager, Clinical Operations

Key Responsibilities

• 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.
• 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.
• 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.
• Aid in DEA communications and audit response preparation.
• Facilitate communication and collaboration between site teams, medical monitors, and senior leadership to address operational issues, share updates, and ensure alignment with study objectives.
• 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