Clinical Research Program / Project Manager

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Job Summary

Qualifications

Overview

The Massachusetts General Hospital Ammon-Pinizzotto Center for Women’s Mental Health (CWMH) provides clinical consultation and research regarding the course and treatment of psychiatric disorders during pregnancy and the postpartum period. The Center also treats women with premenstrual dysphoric disorder and menopause related mood and anxiety disorders. For more information about the clinical and research program, please visit our website at http://www.womensmentalhealth.org.

The Program Manager is responsible for the day-to-day operational management of the Center's clinical research portfolio. The position provides direct supervision of Clinical Research Coordinators and oversees study implementation to ensure research activities are conducted efficiently, consistently, and in accordance with protocol requirements. The position monitors study progress, addresses operational challenges, and ensures achievement of recruitment, timeline, and data quality objectives.

The Program Manager reports to the Director and works closely with the Senior Program Manager to coordinate day-to-day research operations and personnel management. The position collaborates with Principal Investigators, the Center Manager, and the Registry Project Manager to support the successful implementation of the Center's clinical research program.

Core Responsibilities

1. Research Operations and Implementation (45-50%)

• Direct the day-to-day implementation of the Center's active clinical research studies, ensuring adherence to study protocols, timelines, recruitment goals, and operational milestones.
• Translate strategic priorities established by Center leadership into operational work plans and monitor execution across assigned projects.
• Coordinate study workflows including participant recruitment, scheduling, data collection, medical record acquisition, and study tracking.
• Develop and maintain systems to monitor study timelines, deliverables, and operational dependencies.
• Monitor operational performance and identify workflow barriers, implementing routine process improvements and escalating broader operational issues to the Director or Senior Program Manager.
• Coordinate study meetings, prepare agendas, document action items, and monitor completion of assigned tasks.
• Support onboarding and operational training of research personnel on study procedures, workflows, and Center standard operating procedures.
• Ensure implementation of standardized operating procedures across research projects.
• Escalate strategic, scientific, financial, regulatory, or personnel issues requiring leadership decisions to the Director or Senior Program Manager.

2. Personnel Management and Staff Development (25-30%)

• Directly supervise Clinical Research Coordinators, including onboarding, training, coaching, and performance management.
• Assign, prioritize, and monitor staff workload across active studies in collaboration with the Senior Program Manager.
• Conduct regular one-on-one meetings to monitor productivity, professional development, and operational barriers.
• Provide ongoing feedback and coaching to promote staff growth and operational excellence.
• Monitor adherence to study procedures, productivity expectations, and quality standards.
• Identify training needs and coordinate implementation of staff development plans.
• Participate in recruitment, interviewing, hiring, and onboarding of research staff.

3. Grant Development and Research Administration (10–15%)

• Coordinate administrative activities supporting grant proposal development and submission.
• Develop grant timelines and monitor completion of proposal components.
• Assemble proposal materials including biosketches, budgets, supporting documentation, and institutional forms.
• Coordinate submission activities with institutional research administration offices.
• Assist investigators with progress reports, Just-in-Time requests, and post-award administrative requirements.
• Maintain internal tracking systems for proposal submissions, funding outcomes, and reporting deadlines.

4. Research Data and Scientific Support (10–15%)

• Coordinate data quality assurance activities and ensure completeness of research datasets.
• Perform routine data cleaning and validation to support investigator and biostatistical analyses.
• Generate recruitment reports, study metrics, and operational dashboards.
• Assist investigators with preparation of tables, figures, abstracts, and manuscript materials.
• Coordinate manuscript development timelines, version control, journal submissions, and revision tracking.

Qualifications

Required Qualifications

• Bachelor's degree in psychology, public health, health sciences, biological sciences, or a related field.
• Minimum of 3–5 years of progressively responsible experience in clinical research, research administration, or program management.
• Experience coordinating human subjects research and working with Institutional Review Boards (IRBs).
• Experience supervising or mentoring research staff.
• Experience managing multiple concurrent projects and competing priorities.
• Experience using REDCap and Microsoft Office applications, including Excel.

Preferred Qualifications

• Master's degree in psychology, public health, health administration, clinical research, or a related field.
• Experience supporting grant submissions and post-award research administration.
• Experience with manuscript preparation and scientific publications.
• Familiarity with statistical software (e.g., SPSS, R, SAS, or similar) sufficient to support routine data management and reporting.
• Experience working in an academic medical center or federally funded research environment.

Skills and Competencies

• Demonstrated experience managing the operational implementation of clinical research studies, including participant recruitment, study coordination, regulatory activities, and data management.
• Demonstrated knowledge of Good Clinical Practice (GCP), human subjects protections, and federal and institutional regulations governing clinical research.
• Demonstrated ability to supervise, coach, and develop research staff.
• Ability to delegate effectively, establish priorities, and promote accountability.

• Excellent organizational and project management skills with the ability to coordinate multiple concurrent initiatives.
• Strong attention to detail while maintaining awareness of broader program objectives.
• Ability to anticipate operational challenges, develop practical solutions, and follow issues through to resolution.
• Ability to recognize issues requiring escalation and communicate them appropriately.

• Excellent written and verbal communication skills.
• Ability to communicate effectively with investigators, research staff, sponsors, institutional offices, and external collaborators.
• Ability to synthesize and present information clearly to diverse audiences.

• Demonstrated sound judgment and ability to make independent operational decisions.
• Ability to exercise discretion when handling confidential personnel and research information.

Additional Job Details (if applicable)

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EEO Statement:

Mass General Brigham Competency Framework

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