Program Manager, Division of Pulmonary, Critical Care & Sleep Medicine

Job Responsibilities

Program Management: overseeing the conduct, progression, and compliance of all clinical research in the Division of Pulmonary, Critical Care & Sleep Medicine

• Develop, implement, monitor, and support Standard Operating Procedures (SOPs) and work processes to ensure efficient clinical operations.
• Execution and management of all trial tasks from proposal stage to study close out, including and not limited to: site initiation, activation, staff onboarding, staff training, development planning, compliance and regulatory review/approval/submissions.
• Delivers oversight and direction to research coordinators and other study personnel
• Reviews progress of projects regularly and guides research staff to proactively initiate appropriate actions to achieve studies target objectives.
• Acts as a resource to address issues related to participant accruals and advises research staff to ensure milestones adhere to project timeline.
• Organizes and leads regular project meetings to ensure completion of project activities within projected timelines and as outlined in study protocols.
• Communicates project status to Principal Investigators and other concerned parties.
• Cultivate and ensuring close relationships with PIs and CO-Is, research directors, team leads and coordinators
• Creation and distribution of study materials, progress updates, sponsor reports, scientific reports, accrual reports, DSMB reporting, regulatory amendments, and ad hoc reports to stakeholders.
• Creation of protocols, ICFs, and amendments,
• Identify operational issues with program/studies and develop sound strategic solutions and discuss implementation with PIs. Monitor troubleshooting interactions with study partners and external vendors (NYULH cores)
• Creation, development and management of all key trial material (protocol manual of operations, SOPs, eCRFs, CRF Completion Guidelines, Working Practices, Training materials, etc.)
• Ensure proper study setup which may include ordering supplies, establishing petty cash/ patient reimbursements, study advertising or distribution of materials, etc.
• Triage issues raised by assigned teams and ensure review and resolution
• Ensure regular team meetings are held to review and track site activities/progress
• Develop standards and serve as an escalation point for staff to monitor trial performance, adherence, poor enrollment, etc.
• Assist with database builds in REDCap and monitor data entry
• Responsible for evaluating industry-sponsored clinical trials during start-up and determining study prioritization in alignment with operational capacity, timelines, and strategic objectives.
• Monitors clinical research billing compliance to ensure adherence to institutional policies
• Oversees research billing compliance and revenue tracking through CRMS, identifying discrepancies, optimizing workflows, and ensuring timely sponsor invoicing and financial reconciliation across all studies
• Provide leadership and training to research coordinators and staff on best practices for using Epic Research tools, ensuring data integrity compliance with institutional policies and regulatory requirements
• Lead the development and implementation of audit readiness plans, providing guidance and training to staff on regulatory requirements, data integrity, and documentation standards
• Facilitate regular internal reviews and mock audits to proactively identify and mitigate compliance risks within the research portfolio
• Oversee and ensure accurate completion of MyTime entries for research staff
• Oversee the management and regulatory compliance of Investigational New Drug (IND) applications, ensuring timely submission, maintenance, and reporting to the FDA and other regulatory bodies

IRB: Develops new IRB protocols with PIs and oversees research associates' efforts regarding IRB submission and renewals. Works with research associates in the resolution of all issues and assists in resolving complex processing problems. Maintains awareness of study regulatory status and works with research staff to ensure regulatory documents are up to date and on file. Monitors any potential outward effects or issues regarding patient/subject safety and reports to the Principal Investigator.

Supervision: Recruits, hires, trains, and manages workflow of research support staff (e.g. Research Coordinators, Research Data Associates, Research Technicians) and helps secure interim staffing as needed. Clearly communicates expectations/competencies for performance in each role and addresses performance issues proactively. Provides ongoing mentorship and support for staff professional development activities. Manage and coordinate staff call-outs, vacation requests, and leave schedules to ensure adequate coverage and minimal disruption to research operations. Assist research staff and new hires requiring visas by coordinating visa application processes, documentation, and timely submission in collaboration with the institutions Immigration Services team. Lead the onboarding process for research volunteers, ensuring completion of all required documentation, training, and compliance with institutional and study-specific protocols

Training: Provides in-house training to research support staff on topics that will enhance professional development and increase competence in completing assigned duties. Plans, develops materials and other training tools, and creates presentations for training and educational sessions and other activities on an ongoing basis.

Finance & Budgeting Duties: contribute and propose edits/corrections to the development of proposed budgets, renewals, contracts.[AB2] Reconciliation management and tracing of study milestones, participant payments, and core lab service invoicing. Reviews and tracks research-related billing activities to ensure consistency with approved budgets and regulatory standards. Collaborates with finance and clinical teams to monitor billing compliance, ensuring research-related services are billed appropriately to study accounts or third-party payers

Grants: work with Division Grants Manager and Administrator to coordinate preparation of industry sponsored grant activities, submissions and proposals[AB3] .

Decision Making / Problem Solving: combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non-solved issues / questions to supervisor.