Sr Program Manager - Clinical Research Operations

About the OpportunityJOB SUMMARYThe 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 QualificationsBA/BS with at least 10 years of experience managing a clinical-research environment OR an advanced degree with at least 7 years of relevant experienceMinimum 5 years managing complex, longitudinal research projects involving human subjects, including childrenDemonstrated experience supervising, training and mentoring staff across career stagesFinancial management and budgeting experience, including budget reporting from federal and private grantsProficiency with IRB processes, human subjects and clinical research regulationsMeticulous attention to detail, exceptional organizational and time management abilitiesExcellent written and verbal communication skillsPreferred QualificationsAdvanced degree in psychology, public health, early childhood education or related field, or a specialized certification in project/program management15 plus years of experience managing clinical trials or clinical research related to autism, genetic, or neurodevelopmental differencesProficiency with clinical research regulatory processes, including clinical measure development and FDA-related complianceKEY RESPONSIBILITIES & ACCOUNTABILITIESProgrammatic Management & Administrative SupportCollaborate closely with the PI to translate long-term research goals into multi-year operational plans includingStaffing modelsMilestone frameworksBudget estimatesData management pipelinesEnsure official requirements and milestones are met in a timely mannerStrategically analyze metrics to assess progress towards research goals and quality assurance; independently modify protocols to streamline progress and oversee implementation across staffCommunicate regularly with PI about lab progress, study protocols and changes, and staffingCommunicate regularly with internal and external collaborating investigators; schedule and coordinate meetings, agendas, and follow-throughHelp prepare policy documents (e.g., governance policies, publication policies) for complex multi-site longitudinal clinical research studiesPrepare travel arrangements for lab members, as neededPrepare regular study- and grant-related progress reports for internal and external use, including collaborators, donors, foundations, and federal agenciesRegulatory Compliance, IRB, & Contract ManagementEnsure 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 projectsCoordinate with third-party central IRB providers for relevant projectsWrite and oversee the execution of reliance agreements, data use agreements, and scopes of work with external collaboratorsEnsure compliance with university and other relevant regulations (e.g., NIH, FDA) in record tracking and data auditingSupervision & Team DevelopmentSupport PI in staff hiring processes, including job requisitions, candidate selection, onboarding, and trainingCo-supervise junior research staff and support their professional developmentManage staff performance reviews; provide regular feedback on work, project milestone progress, and responsibilities of study team membersDevelop and manage resources to support lab and research activities, including lab manuals and procedural documentsFinancial ManagementMonitor all lab expenses, including salaries, across 3+ concurrent grants, supported by University’s financial staffAct as a liaison between lab and the University’s grant and finance departmentsPrepare financial progress reports for internal and external use, including university personnel, foundations, and federal grant stakeholdersCreate and maintain audit-ready recordsDOCUMENTS REQUIRED:ResumeCover LetterPosition TypeResearchAdditional InformationNortheastern University considers factors such as candidate work experience, education and skills when extending an offer.  Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.   All qualified applicants are encouraged to apply and will receive consideration for empl