Sr Program Manager - Clinical Research Operations

About the role

JOB SUMMARY The Neurodevelopmental Dynamics (NDD) Lab conducts multidisciplinary research at the intersection of science, engineering, and clinical health. Our goal is to better understand and augment communication from individuals with complex neurodevelopmental differences, including those with autism, intellectual disabilities, rare genetic disorders and minimal spoken speech. We work closely with individuals and families at the heart of our mission to ensure our research aligns with real-world impact. We are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. This is a senior management position requiring deep expertise in clinical research management, independent judgement and a demonstrated ability to collaborate across a multidisciplinary program. The Senior Program Managing Director will serve as the primary liaison to the Principal Investigator, directing a team of 6-12 staff, students and trainees, overseeing a diverse portfolio of federal and private grant funding (>$25M for the next five years). This role requires the frequent use of novel problem-solving strategies, planning, procedural adaptation, and overseeing lab milestones. Decisions made in this role directly affect the scientific integrity and mission of the lab. We expect this individual to be an expert in their field. This position offers a 2-year initial commitment with the potential for extension based on performance, budget, and lab needs. MINIMUM QUALIFICATION: Required Qualification s BA/BS with at least 10 years of experience managing a clinical-research environment OR an advanced degree with at least 7 years of relevant experience Minimum 5 years managing complex, longitudinal research projects involving human subjects, including children Demonstrated experience supervising, training and mentoring staff across career stages Financial management and budgeting experience, including budget reporting from federal and private grants Proficiency with IRB processes, human subjects and clinical research regulations Meticulous attention to detail, exceptional organizational and time management abilities Excellent written and verbal communication skills

Requirements

• Advanced degree in psychology, public health, early childhood education or related field, or a specialized certification in project/program management
• 15 plus years of experience managing clinical trials or clinical research related to autism, genetic, or neurodevelopmental differences
• Proficiency with clinical research regulatory processes, including clinical measure development and FDA-related compliance
• KEY RESPONSIBILITIES & ACCOUNTABILITIES
• Programmatic Management & Administrative Support
• Collaborate closely with the PI to translate long-term research goals into multi-year operational plans including
• Staffing models
• Milestone frameworks
• Budget estimates
• Data management pipelines
• Ensure official requirements and milestones are met in a timely manner
• Strategically analyze metrics to assess progress towards research goals and quality assurance; independently modify protocols to streamline progress and oversee implementation across staff
• Communicate regularly with PI about lab progress, study protocols and changes, and staffing
• Communicate regularly with internal and external collaborating investigators; schedule and coordinate meetings, agendas, and follow-through
• Help prepare policy documents (e.g., governance policies, publication policies) for complex multi-site longitudinal clinical research studies
• Prepare travel arrangements for lab members, as needed
• Prepare regular study- and grant-related progress reports for internal and external use, including collaborators, donors, foundations, and federal agencies
• Regulatory Compliance, IRB, & Contract Management
• Ensure adherence and compliance with human subjects research policies, including ethics training (e.g., CITI certifications) across all lab members and the sharing and storage of identifiable human-subjects data (PII)
• Prepare, review, submit, and manage IRB applications and amendments across multiple multi-site clinical longitudinal projects
• Coordinate with third-party central IRB providers for relevant projects
• Write and oversee the execution of reliance agreements, data use agreements, and scopes of work with external collaborators
• Ensure compliance with university and other relevant regulations (e.g., NIH, FDA) in record tracking and data auditing
• Supervision & Team Developmen t
• Support PI in staff hiring processes, including job requisitions, candidate selection, onboarding, and training
• Co-supervise junior research staff and support their professional development
• Manage staff performance reviews; provide regular feedback on work, project milestone progress, and responsibilities of study team members
• Develop and ma

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Company Intel

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