Program Manager I - Tisch Cancer Institute - Mount Sinai Morningside : Job Details

DescriptionJob DescriptionThe Program Manager I (PM)is responsible for providing administrative, operational and programmatic oversight of the Protocol Review and Monitoring System. The PM is responsible for all ensuring that all cancer-related clinical research receives appropriate peer-review prior to activation and then regular monitoring for scientific progress.The Program Manager will have a thorough knowledge of institutional, PRMC policies and procedures and National Cancer Institute (NCI) guidelines related to cancer clinical trials. The PM coordinates all activities of the scientific committees (disease focus groups, protocol review and monitoring committees), including scheduling meetings, preparing agendas and meeting materials, and documenting minutes. The PM manages the intake process, and all correspondences with Principal Investigators regarding protocol approvals, amendments, and stipulations. The PM execute decisions regarding expedited approval and studies needing administrative approval. The PM facilitates compliant documentation and capture of clinical trials data within our clinical trials management system (OnCore).The PM is instrumental in developing program policies, procedures, workflows and tools that promote operational efficiency and is responsible for producing routine metric reports for leadership evaluation. The PM is accountable to the PRMS Chairs, PRMS Director and reports to the Executive Director, Enterprise Cancer Clinical Research.Responsibilities

• Ensure the smooth operation and regulatory compliance of Protocol Review and Monitoring Committee (PRMC) and Disease Focus Group (DFG) meetings in alignment with NCI guidelines and institutional charters (or equivalent):
• Coordinate all aspects of committee meetings, including agenda preparation, meeting materials, meeting minutes, attendance logs, document decisions, timely dissemination of materials, reviewer assignments, attendance tracking, minute-taking, meeting facilitation and preserving the integrity of the voting processes.
• Oversee the PRMS intake process by screening protocol submissions for completeness and accuracy, confirming all required documents and information are present before committee review, and coordinating with investigators or study teams to resolve discrepancies or deficiencies. Ensures timely resolution of issues to allow protocols to move swiftly through the pre-review process.
• Maintain proactive communication with the committee chair, reviewers, and DFG/PRMC members to coordinate assignments, clarify expectations, and ensure timely completion of reviews, voting, and decision-making in alignment with committee procedures and review timelines. Follows up on outstanding items through resolution.
• Coordinate Corrective Action Plan reviews with DFG Chairs when required by PRMC. Work with PI, research team, and DFG members to develop action plans to increase accrual on low accruing studies; monitor screen failure rates as requested and report back to DFG.
• Promptly identifies and corrects issues or deficiencies to minimize committee disruptions and/or delays.

• Lead quality assurance activities across the PRMS to ensure accurate documentation, scientific rigor, and NCI-designated cancer center compliance.
• Responsible for validating key fields required for NCI reporting and TCI leadership reporting (i.e. risk classification, rare cancer designation, sponsor type, protocol primary purpose, target annual accrual. Periodically audits data entries in OnCore and PRMS databases to confirm accuracy and consistency with meeting outcomes and institutional policies.
• Perform quality checks of DFG and PRMC review documentation, including decision trees, priority scores, review forms, meeting minutes and corrective action plans, to ensure data completeness and process fidelity.
• Maintain accurate, centralized records of committee decisions, protocol status, and meeting materials using standardized templates and organized trackers to support reporting, audit readiness, and operational transparency.

• Coordinate and manage all communication streams related to the PRMS to ensure transparency, alignment, and timely dissemination of information across TCI
• Serves as the primary point of contact for committee chairs, members, research community, investigators, and TCI leadership, responding to inquiries and facilitating issue resolution.
• Draft, distribute, and track outcome letters and formal committee communications to investigators/study teams, ensuring clarity of review outcomes, required revisions, and next steps; coordinate messaging between PRMC, DFG/MFG, FFR, IRB, and DSMC, as appropriate.
• Establish and maintain consistent communication with ancillary offices such as the IRB, Clinical Research Support Unit (CRSU), and Financial Feasibility Review (FFR) and Community Outreach and Engagement (COE) to align processes, reduce delays, and support operational efficiency.
• Prepare institutional memos and deliver presentations to the research community about relevant committee functions and changes.
• In conjunction with committee Chairs, develop high-quality content and ensure timely delivery of relevant information—including biannual performance reports, trend summaries, and issue escalation updates—to the Clinical Research Steering Committee (CRSC), enabling informed oversight and institutional accountability.

• Execute administrative functions of the PRMS
• Conduct administrative review and approval of protocols that do not require full board review, including determination and issuance of waivers, exemptions, and other independent review decisions; consult with chairs as needed to ensure appropriate adjudication and documentation.
• Provide interpretation of committee policies and offer guidance to investigators, study teams, and chairs on process navigation, potential resolution pathways, and appropriate tactical routes for protocol progression.
• Support committee membership management, including rosters, onboarding, term tracking, monitoring of good standing, and presentation of new member nominations to leadership.
• Maintain confidentiality in all committee proceedings and communications.
• Coordinate honorarium payments, CME activities and conflicts of interests related to the PRMS.
• Fulfill obligations as an ancillary reviewer in the IRB system (RUTH) timely.

• Design, deliver, and manage comprehensive training and education strategies to ensure consistent understanding, adherence, and effective participation in PRMS processes across Tisch Cancer Institute.
• Serves as a subject matter expert with comprehensive knowledge of PRMS policies and procedures, providing guidance and promptly addressing inquiries from committee members, investigators, and research staff accurately, consistently and completely.
• Coordinates PRMS member orientation, including member orientation video, meet with the new member to formally review policies and procedures and software systems, arrange meeting observations, review responsibilities, and assigns a mentor, as applicable.
• Assesses training needs across PRMS members, chairs, investigators, study teams, and research units (e.g., regulatory affairs), and develops targeted educational content and strategies to address identified knowledge or process gaps.
• Delivers basic education and training at new employee orientation, organizes and delivers bootcamps or equivalent workshops.
• Promotes policy adherence by educating the research community and committee members on review responsibilities, facilitating timely scientific review and re-review of cancer clinical trials, and guiding appropriate triage through established review pathways.

• Ensure accurate, complete, and accessible documentation across PRMS systems to support regulatory compliance, data integrity, and operational efficiency.
• Implement and maintain logical, user-friendly electronic storage mechanisms with standardized naming conventions, folder structures, and version control to facilitate easy access and long-term traceability.
• Develop and manage clear, concise tracking tools with appropriate labels, legends, and definitions to support transparency, progress monitoring, and audit readiness.
• Maintain accurate and complete records in OnCore and ensure information in the IRB system is quality-checked, verified, and corrected as needed to reflect current protocol status, classifications and review type (i.e. concurrent) and outcomes.
• Maintain accurate documentation and data integrity in clinical trial management systems (e.g., OnCore), and monitor review timelines and protocol progress (i.e. dashboards) to support NCI-mandated tracking and reporting.
• Maintain and update Charter, user manuals and PRMS operating manual (or equivalent) to ensure standard operating practices across the health system.

• In conjunction with the Executive Director of Systems and Data, manage, and present accurate, timely, and actionable reports to support oversight, strategic planning, and compliance for the PRMS.
• Prepare and present metrics and analytic summaries to the Chairs, CRSC, Cancer Center leadership
• Prepares reliable and accurate program data for routine meetings.
• Monitor dashboards and review timelines to ensure timely PRMS review and re-review of protocols, proactively identifying delays or process gaps for resolution.
• Produces high-quality, validated data and ad-hoc reports for TCI, external advisory board (EAB) and NCI required reporting.
• Participates in the preparation of the grant progress reports and renewal application.
• Process improvement
• Monitor dashboard and other reports to identify enhancement areas and presents new ideas to leadership.
• Updates to forms and software systems in conjunction and with approval by the Exec director data management

Lead and support continuous process improvement initiatives to optimize PRMS efficiency, compliance, and stakeholder experience.

• Identify and analyze workflow inefficiencies, recurring bottlenecks, or deviations from review timelines, and propose solutions to streamline operations.
• Collaborate with committee members, study teams, and research units to pilot, refine, and implement enhancements to PRMS policies, tools, procedures and technical systems.
• Monitor and evaluate the impact of implemented changes using key metrics and stakeholder feedback to ensure sustained improvements and alignment with NCI expectations and institutional goals.
• Maintains liaison with staff in other departments to coordinate program activities and training; to accomplish program objectives; and to ensure cooperative efforts are enhanced and available resources are utilized.
• Administers program procedures and systems. Ensures information is disseminated to research community regarding PRMS.
• Confers with and advises staff and others to provide technical advice, problem solving assistance, answers to questions and program goals and policy interpretations; refers to appropriate department or person when unable to respond.
• Develops and independently implements new or revised program goals, strategies and objectives to sustain and grow programs and services.
• May perform needs assessment, analyzes and report results for basis of program development or quality improvement.
• Oversees and manages the activities of subordinates and consultants and provides leadership and direction for staff, if applicable, setting an effective agenda to ensure that performance goals are met.
• Performs other related duties.

Qualifications

• Bachelors degree or greater preferred, or a combination of applicable experience and education
• 3+ years experience (5 preferred), managing and administrating program activities for assigned area
• Excellent written and oral communication skills
• Excellent organizational skills and the ability to prioritize multiple tasks, projects and assignments
• Exceptional attention to detail and accuracy

Employer DescriptionStrength through Unity and InclusionThe Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.About The Mount Sinai Health SystemMount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high Honor Roll status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's “Best Children's Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's “The World's Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.Equal Opportunity EmployerThe Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.CompensationThe Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $64526.72 - $123599.87 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.#J-18808-Ljbffr