Cinical Research Program Manager, Center for Regenerative Medicine

Hospital for Special Surgery•New York, NY

8d•$72,000 - $109,500

About The Position

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

Requirements

Minimum of 5+ years of experience with clinical research operations.
Bachelors or Masters level EDUCATION 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.

Nice To Haves

PhD, MD or MPH.
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.

Responsibilities

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.