Program Manager I - Tisch Cancer Institute

The 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. 

• 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 Financi