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Adams Clinical

Performs late-phase, double-blind psychiatric trials

Senior Manager / Site Director - Clinical Operations

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeBoston, MA, USAIn-person

About the Job

Requirements

  • A bachelor's degree is required.
  • Knowledge of Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations, and clinical trial protocols is required.
  • Strong communication, collaboration, and organizational skills are required.
  • Strong decision-making and problem-solving skills are required.
  • Ability to prioritize competing responsibilities in a fast-paced environment is required.
  • For the Senior Manager, Clinical Operations level, at least 2 years of people-management experience in clinical research is required.
  • For the Site Director, Clinical Operations level, at least 4 years of people-management experience in clinical research is required.
  • For the Site Director, Clinical Operations level, site-network operational experience is required.
  • For the Site Director, Clinical Operations level, clinical research financial experience is required.

Responsibilities

  • Serve as the primary contact for day-to-day site issues and monitor outpatient study activities, enrollment, visit schedules, and site performance metrics.
  • Support subject recruitment, eligibility assessments, and randomization; oversee study processes, including ALCOA-compliant documentation, study trackers, investigational product handling, and appropriate handling and reporting of participant safety events and adverse events, including serious adverse events and adverse events of special interest.
  • Identify operational, regulatory, or safety risks; implement mitigation strategies with senior leadership and escalate critical issues.
  • Collaborate with Finance to review Clinical Trial Agreement invoicing, oversee participant reimbursements, and support site-level budget monitoring and forecasting.
  • Review monthly profit-and-loss results and present the prior month's performance to network senior leadership each month.
  • Monitor screening outcomes and operationally preventable screen-failure trends, identify recurring issues, and work with site study teams and Clinical Operations leadership on process improvements.
  • Make day-to-day site decisions autonomously and escalate matters requiring network alignment, senior-leadership input, or clinical or medical expertise.
  • Foster a collaborative and accountable site culture; address employee concerns, conflict, and performance issues; advocate for staff while balancing organizational expectations; and translate leadership priorities into clear expectations.
  • Lead, train, and develop Clinical Research Coordinators, Research Assistants, and Laboratory Technicians; assign responsibilities and track staff involvement across studies.
  • Collaborate with and support principal investigators and medical sub-investigators.
  • Oversee recruitment, hiring, and onboarding of key site personnel, including principal investigators, clinicians, nurses, data safety managers, Clinical Research Coordinators, and Research Assistants; conduct regular team huddles to review study progress.
  • Coordinate resources, streamline processes, and drive operational excellence with leaders across departments and sites, including the Associate Director and Vice President of Clinical Operations. The position reports to the Associate Director of Clinical Operations.
  • Oversee facility and building maintenance, including office services, safety inspections, drug-room security, and pest control; ensure efficient use of site space and adequate staff workspaces.
  • Coordinate research-equipment calibration and support renovation, expansion, and relocation projects.
  • Manage local vendor contracts for study-related services, including laboratories and imaging.
  • Represent the site at pre-study site visits and site initiation visits, and serve as an expert on site resources and standard operating procedures.
  • 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 Drug Enforcement Administration communications and audit-response preparation.
  • Facilitate communication among site teams, medical monitors, and senior leadership to address operational issues, share updates, and align with study objectives.
  • Serve as a primary contact for sponsors, monitors, and other external stakeholders on operational and regulatory matters.
  • Generate and review site performance reports for leadership and sponsors.
  • For the Site Director level, partner with Clinical Science leadership and network clinical experts to support training, assessment quality, therapeutic-area knowledge, appropriate staffing, and consistent study execution.
  • For the Site Director level, support the coordination, development, and performance of clinician sub-investigators, including training needs, resource planning, and study staffing.
  • For the Site Director level, collaborate with central clinical science leadership and participate in relevant Clinical Science meetings to support clinician development, coaching, quality, and consistency across the network.
  • For the Site Director level, monitor clinical screening outcomes and screen-failure trends, identify clinical factors or assessment findings contributing to failures, and work with clinicians and clinical leadership to improve assessment consistency, eligibility determination, and screening quality.
  • For the Site Director level, partner with network clinical experts to provide clinicians with appropriate training and support in study-specific clinical assessments, therapeutic-area expertise, participant safety, clinical-risk considerations, placebo-response mitigation, and other clinical aspects of protocol execution.
  • For the Site Director level, support consistent clinical practices across the site and network, escalating clinical questions or concerns to appropriate clinical leadership.

Desired Qualifications

  • For the Senior Manager level, 4 or more years of clinical research experience is preferred; hands-on experience as a Clinical Research Coordinator is a plus.
  • For the Senior Manager level, prior research-site management experience is a plus.
  • For the Site Director level, 6 or more years of clinical research experience is preferred; prior hands-on experience as a Clinical Research Coordinator is a plus.
  • For the Site Director level, director-level experience is strongly preferred.
  • For the Site Director level, experience conducting or administering clinical research assessments is a plus, including psychiatric or neurological instruments such as MADRS, HAM-A, HAM-D, C-SSRS, and MMSE.

About the Company

Adams Clinical

Performs late-phase, double-blind psychiatric trials

Adams Clinical runs late-phase psychiatric and neurologic clinical trials under FDA rules, using double-blind, randomized, placebo-controlled designs to test investigational drugs that have already shown initial promise. Nine full-time doctors act as neutral observers to ensure unbiased results, and coordinators with medical training help maintain data integrity through careful participant selection and standardized procedures. They provide external testing required by law (21 CFR Part 54) for the pharmaceutical industry, earning revenue from pharma companies seeking evidence of efficacy and safety. Their goal is to produce reliable, high-quality data that regulators can use to make decisions on new psychiatric and neurologic drugs, with a special focus on depression research.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Watertown, MA
Founded
2011

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