Clinical Research Program Manager

maximize the abundant opportunities for growth and success.

If this describes you then let’s talk!

HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.

Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.

Emp Status

Regular Full time

Work Shift

Day (United States of America)

Compensation Range

The base pay scale for this position is $72,000.00 - $109,500.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.

Job Description

What you will be doing

The Clinical Research Program Manager for the Center for Regenerative Medicine (CRM) is responsible for the planning, execution, and implementation of clinical research studies focused on regenerative medicine therapies across the Hospital for Special Surgery (HSS) Main Campus and Satellite Sites, supervising CRM staff and collaborating partners. The position is embedded within the Center for Regenerative Medicine and reports directly to the Chair and Medical Director of the CRM.

This role provides research support and partnership for investigator-initiated and industry-sponsored studies, including retrospective, prospective, and randomized clinical trials. The Program Manager will ensure that studies are conducted efficiently, and in compliance with regulatory, institutional, and ethical standards. The Program Manager will work with multi-department, multi-disciplinary, and multi-center teams, partnering with physicians, scientists, Clinical Research Administration (CRA), Legal, Finance, Compliance, IT, and Laboratory departments

Years Of Experience Required
• Minimum of 5+ years of experience with clinical research operations.

Position & Unit Accountabilities

Clinical Research Operations, Study Set-up, Oversight, Regulatory Compliance, and Study Closeout
• Provide operational leadership, direction and oversight for the full lifecycle of clinical research studies and clinical trials, from study start-up through close-out, overseeing Clinical Coordinators and Research Assistants, collaborating with study Principal Investigators (PIs).
• Oversee protocol implementation, patient screening, enrollment, follow-up, data collection, and study execution in accordance with regulations and institutional policies.
• Develop and implement strategies to ensure trial operational efficacy, including developing and implementing strategies to meet enrollment targets across CRM studies and HSS sites.
• Ensure compliance in accordance with sponsor, institutional, and departmental requirements, including IRB approvals, amendments and continuing reviews, and study close-outs.
• Ensure regulatory compliance, leading and overseeing regulatory binders, and collaborating with the study teams in partnership with CRA to ensure that all documentation and binders are ready for internal and external audits.
• Lead continuous quality improvement initiatives for research operations, updating practices in alignment with evolving regulatory and industry standards.
• Serve as the primary operational liaison for Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and study budgets in collaboration with CRA, Legal and Finances.

Data, Analytics & Research Infrastructure
• Supervise Research Assistants, Clinical Research Coordinators and other CRM staff to oversee research data collection into the CRM Registry, ensuring accuracy, completeness, and integrity.
• Lead CRM Registry operations, including oversight of data collection tools, dashboards, and self-service reporting (Epic, PROMs, and related systems).
• Collaborate with IT and analytics teams to enhance research data rigor, visibility, extraction, and reporting capabilities.
• Perform advanced data queries and contribute to data analysis in collaboration with investigators and the HSS Center for Biostatistics.
• Ensure the integration of Regenerative Medicine Product analyses (e.g., CBC-Diff on PRP) into standard-of-care laboratory analyses, collaborating with the Department of Pathology and Laboratory Medicine

Cross-Functional Integration
• Partner with Clinical Operations and Research Teams to ensure alignment between Clinical Research Operations, Clinical Operations and the Research (laboratory) enterprise.
• Support enterprise-wide integration of regenerative medicine research into clinical operations on an as-needed basis, including Epic workflows and patient care pathways.
• Ensure CRM research communications, promotional materials, and websites to adhere to FDA regulations governing regenerative medicine.
• Provide supervision and support to research staff, including Research Fellows, Research Coordinators & Assistants, responsible for the conduct of clinical studies.
• Partner with our finance team to build budgets, monitor study expenditures and milestone completion; ensure financial sustainability and alignment with funding sources.

Education Required

Bachelors or Masters level

Education Preferred

PhD, MD or MPH.

Skills Required
• Demonstrated experience across the Clinical Research lifecycle, including study design, start-up, implementation, monitoring, regulatory submissions, data management, and close-out; experience in a high-volume academic or hospital-based research environment strongly preferred.
• Working knowledge of FDA regulations, ICH-GCP, human subjects protections, and HIPAA requirements, with experience managing high-level studies and confidential information.
• Strong project management skills with the ability to manage multiple concurrent studies, prioritize competing deadlines, and proactively mitigate risks.
• Excellent written and verbal communication skills, with the ability to engage effectively with physicians, clinical and research staff, administrative leadership, sponsors, and external partners.

Skills Preferred
• Experience with electronic medical record and data capture systems, including Epic, REDCap, and other clinical research technologies.
• Highly organized, detail-oriented, and adaptable, with a collaborative and professional approach to work and feedback.

PHYSICAL WORKING CONDITIONS

Sitting in a comfortable position with frequent opportunity to move about Sitting in a comfortable position with frequent opportunity to move about the department and traverse the hospital campus. Examples: executive, management, administrative and secretarial positions.

ENVIRONMENTAL WORKING CONDITIONS

Comfortable indoor area Located in a comfortable indoor area. Examples: executive, management and secretarial positions.

HAZARDS OSHA

Category 3 Tasks that involve no exposure to blood, body fluids, tissues, or other potentially infectious materials and Category 1 tasks are not a condition of employment.

Non-Discrimination Policy

Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.