Job Description

Position Summary:
We have an exciting opportunity to join our team as a Project Manager.

The Clinical Translational Science Institute (CTSI), Clinical Research Centers (CRC) is seeking a highly motivated and organized individual to join our institution as a Project Manager (PM) of the Cell and Gene Therapy (CGT) team. Reporting to the associate director for research operations of the CTSI, the PM will provide strategic planning, development, and programmatic expansion of the CGT group and insure expedited activation and study start-up of all clinical trials and patient enrollments.

The PM, working with the associate director and GCT medical director, will be responsible for the development, coordination, and submission of clinical trial regulatory documents, conducting amendments, continuing reviews and modifications in compliance with institutional policies, contractual obligations, and applicable regulations. Working in collaboration with departments and the NYU Perlmutter Cancer Center, the PM will ensure seamless study operations in clinic, data acquisition, and laboratory processing. The role includes operational oversight of a newly created cell therapy team and coordination across the continuum of the study life cycle (pre and post-award through activation), assigned clinical, data, and lab duties. The PM will work closely with principal investigators, departmental research teams, the Office of Science and Research (OSR) units of budgeting, contracts, sponsored programs, billing compliance, and the IRB and the CTSI executive and associate directors, nurse managers. The position also requires regular contact with departments, sponsors, outside institutions, and federal agencies. The position will supervise and manage staff within a newly created CGT team. The role requires expertise in project and staff management and regulatory affairs.

Job Responsibilities:

Program Management & Operations

1. Provide operational management and support for the Cell and Gene Therapy (CGT) research program within the CTSI Clinical Research Centers.
2. Partner with the Associate Director of Research Operations and CGT Medical Director to support program development, growth, and implementation of clinical, lab, and regulatory operational priorities.
3. Lead and coordinate the activation and execution of CGT clinical trials, ensuring efficient study start-up, patient enrollment readiness, and ongoing study support.
4. Develop, standardize, and continuously improve workflows, SOPs, tools, and operational processes to support compliant, efficient, and high-quality CGT research operations.
5. Support expansion of the CGT program by identifying operational gaps, improving infrastructure, and implementing process improvements across the clinical trial lifecycle.

Study Start-Up and Regulatory Affairs

1. Oversee end-to-end study start-up activities for CGT protocols, including protocol intake, feasibility review, site activation planning, and startup milestone tracking.
2. Manage operational and regulatory activities across the full study lifecycle, including pre-award, post-award, activation, maintenance, amendments, continuing review, modifications, and study closeout activities, as applicable.
3. Ensure all regulatory submissions and post-approval activities are completed in compliance with institutional requirements, sponsor obligations, Good Clinical Practice (GCP), and applicable federal and local regulations.
4. Collaborate with principal investigators, study teams, institutional departments, and sponsors to ensure study requirements are operationalized effectively.
5. Maintain audit-ready regulatory and operational documentation and support responses to internal reviews, sponsor audits, and regulatory inspections.

Clinica, Data, Lab Operations

1. Oversee and coordinate operational activities across clinical, data, and laboratory functions for CGT studies to ensure seamless study conduct.
2. Partner with investigators, research coordinators, research nurses, laboratory personnel, and collaborating departments to ensure protocol-specific procedures are executed accurately and efficiently.
3. Facilitate coordination with the NYU Perlmutter Cancer Center and other institutional partners to align clinical care, research workflows, specimen handling, and data collection requirements.
4. Support integration of protocol requirements into day-to-day clinical and research operations, including scheduling, specimen processing, data capture, and documentation workflows.
5. Ensure effective communication and handoff across all stakeholders involved in study implementation and participant management.

Staff Supervision, Reporting, and Communication

1. Supervise and manage staff within the newly created CGT team, including assigning work, setting priorities, monitoring performance, and supporting professional development.
2. Train, mentor, and onboard team members in study operations, regulatory requirements, institutional processes, and CGT-specific workflows.
3. Track program metrics, startup timelines, enrollment readiness, and operational performance indicators.
4. Serve as a key point of contact for internal departments, sponsors, outside institutions, and federal agencies as needed for program and study-related matters.
5. Represent the CGT program and CTSI Clinical Research Centers in meetings, committees, and cross-functional workgroups.
6. Maintain effective communication with leadership, investigators, research teams, and external partners to ensure alignment on priorities, expectations, and timelines.

Minimum Qualifications:
To qualify you must have a o Bachelors Degree in a business-related field or science (Required)
o At least 5 years experience in: clinical trials, clinical research, healthcare administration
o Experience with clinical research operations and/or billing compliance in academic, healthcare, or industry settings.
o Knowledge, skills, and abilities in budgeting and accounting
o General medical and research terminology
o Strong computer skills, including proficiency with Microsoft Office (Word, Excel, Outlook) and the ability to learn institutional clinical research management systems.
o Excellent organizational, project management, and time management skills; proven ability to manage multiple projects and deliver highquality outputs on time.

Preferred Qualifications:
o Masters degree or above in public health or research
o 5 years experience in clinical research administration and budgeting
o Direct experience in financial planning of clinical trials (strongly preferred)
o Ability to manage multiple projects simultaneously and deliver consistently high-quality outputs on time.
o Experience managing clinical research and teams in an academic or pharmaceutical setting.
o Knowledge of good clinical practice guidelines and federal regulations
o Excellent organizational, project management, and time management skills. Attention to detail and commitment to maintaining high standards of quality.
o Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
o Ability to adapt to changing priorities and work in a fast-paced environment.
o Computer literacy required with proficiency of basic Microsoft Office software applications.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $70,481.61 - $95,000.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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