What You'll DoThe Clinical Research Program Manager is the operational lead of the Coordinating Center for a multi-site Lyme disease research program spanning three regional hubs and more than 20 clinical and data-collection sites across New England. Reporting to study leadership, this role provides study-wide project management and serves as the primary regulatory lead for the Tufts single IRB, coordinating across clinical operations, data management, laboratory operations, investigative project teams, documentation, training, and stakeholder communications. The ideal candidate brings strong clinical research operations experience, excellent organizational and communication skills, and the ability to manage complex timelines, cross-functional workflows, and competing priorities across multiple institutions.
- Serve as the operational center of the study through the Coordinating Center, which owns and drives study-wide infrastructure and execution, including procedures, training, participant materials, progress tracking, and cross-group coordination.
- Serve as primary regulatory lead for the Tufts single IRB of record: prepare and maintain submissions, modifications, continuing reviews, reportable new information, consent revisions, reliance agreements, and the study regulatory binder; advise investigators and site staff on compliance strategy across sites.
- Maintain study-wide timelines, milestones, and dependencies; manage risks, decisions, and action items using appropriate project-management tools; and oversee implementation of protocol amendments and operational changes across all hubs and sites.
- Create, maintain, and update study Manuals of Procedures, SOPs, workflows, and controlled documentation.
- Develop and deliver onboarding, refresher, and ongoing training and guidance for study coordinators and site staff across hubs.
- Track enrollment and retention across hubs and sites, identify barriers, develop participant-facing retention materials, and work with hub teams on solutions.
- Serve as operational liaison to the Diagnostic Core (sample-kit logistics, specimen workflows, enrollment-season readiness, consent preferences) and the Data Center (REDCap updates, data requests, reports, data-quality activities), keeping deliverables on schedule and resolving bottlenecks.
- Oversee Tufts hub operations and Tufts-affiliated sites, including site activation, enrollment preparation, and ongoing support; train, onboard, supervise, and support Tufts study coordinators and delegated staff.
Serve as the operational link among the investigative project teams, Data Center, and Diagnostic Core to support sample requests, clinical and diagnostic data needs, analysis support, and selection criteria; prepare enrollment and retention metrics and progress reports for leadership and external stakeholders.
What We're Looking ForBasic Requirements:Knowledge and experience typically acquired by:
- Advanced degree in clinical research, public health, project management, health administration, life sciences, nursing, or a related field, or equivalent experience.
- At least 5 years of progressively responsible clinical research experience, including managing complex, multi-site or multi-institutional studies.
- Strong IRB experience, including single-IRB oversight and negotiating or managing reliance agreements.
- Demonstrated project-management experience: timeline development, milestone tracking, risk management, dependency tracking, and stakeholder communication.
- Experience supervising, training, or leading clinical research staff.
- Experience developing and maintaining MOPs, SOPs, training materials, study workflows, onboarding tools, or controlled documentation.
- Experience supporting study recruitment, enrollment tracking, participant retention, and follow-up workflows, including developing participant-facing retention materials.
- Ability to coordinate work across clinical operations, regulatory, data-management, laboratory, and investigator teams.
- Excellent written and verbal communication skills; strong organizational skills and ability to manage multiple priorities in a fast-paced, highly collaborative environment.
- Knowledge of Good Clinical Practice, human-subjects protections, HIPAA, and applicable clinical research regulations.
- Ability to travel to clinical sites as needed.
Preferred Qualifications:- Experience managing NIH-funded clinical or translational research.
- Familiarity with REDCap sufficient to understand data-team workflows and communicate effectively about data collection, reports, and database changes.
- Ability to independently access and analyze study data using R, SAS, Python, or similar tools to build enrollment, retention, and operational reports that inform decisions.
- Experience coordinating biospecimen collection, laboratory workflows, or biorepository procedures.
- Formal project-management training or certification.
- Familiarity with infectious-disease, longitudinal studies, or biorepository research
Pay RangeMinimum $74,000.00, Midpoint $92,500.00, Maximum $111,000.00
Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range.
