Program Manager

Position Summary

The Division of Pediatric Hematology, Oncology, and Stem Cell Transplant at Columbia Children’s Health, New York-Presbyterian Morgan Stanley Children’s Hospital (MSCH) is one of the oldest and most comprehensive centers in the country focused on treating children with cancer and blood disorders. MSCH has 202 inpatient pediatric beds, including a 54-bed Pediatric Intensive Care Unit and 10 operating rooms. Our division is currently composed of 3 sections (Hematology, Oncology and Stem Cell Transplantation) with 22 full-time faculty, 3 research RN/NP’s, 8 clinical research associates, and 3 regulatory specialists and includes an ACGME-accredited Fellowship Program and a FACT-accredited stem cell transplant program.

We are seeking a Program Manager to work in the Research Capacity to join our team in a full-time position within Oncology for Clinical Research focused on working on the Immuno-Oncology Program (PIRD).

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. Columbia University offers a range of benefits to help you, and your dependents stay healthy, build long-term financial security, meet educational and professional goals, and more. Explore your options for , , , and .

“Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process”

Responsibilities

• Oversee site participation in PRWCC and onboarding of new sites. Oversee research projects and clinical trials and ensure sites are updated and compliant in completing relevant tasks required for participation and advancement of PRWCC research trials. This includes ensuring sites have data managers responsible for data entry, sites have access to data capture tools, sites are trained on data entry, sites are compliant in meeting deadlines required to advance PRWCC research studies, sites have IRB approval for PRWCC relevant research studies, sites have relevant DUAs/MTAs signed to permit data and sample sharing across sites. Managerial role in ensuring sites are trained on study workflow and procedures required for research studies, data entry and sample processing, shipment and sharing.
• Supervise the implementation of and adherence to PRWCC research initiatives and study protocols. Educate PRWCC participants on established protocols, policies, processes, and procedures. Determine effective strategies to ensure all PRWCC participating sites are compliant with regulatory and contractual responsibilities, as determined by the PRWCC, and necessary for execution of PRWCC-related research projects.
• Manage and audit operations, including sample shipment, sample banking, appropriate sample allocation to appropriate location for analysis, accurate and timely data entry, ensure compliance with applicable regulations; provide leadership in identifying and implementing quality control/streamlined procedures and research study and organizational workflow. Monitor Institutional Review Board submissions and respond to requests and questions.
• Work with Clinical research coordinators and PRWCC members (institutional PIs, data managers and research staff) to ensure individuals are appropriately trained and compliant with their responsibilities and roles required to execute effective research and sample/data sharing and monitoring. Generate study workflow and ensure workflow and processes are adhered to across PRWCC institutional participants.
• Provide leadership and expertise in identifying and completing research grants, with the support of PRWCC director and members. Oversee financial resources, as needed, create internal and external budgets for research protocols, with the support of the pediatric hematology oncology division at LPCH, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
• Monitor and oversee PRWCC research efforts and roles and contributions of participating sites, individual consortium participants and PRWCC working groups. Identify gaps in needs required for effective research execution and ensure adequate coverage for research workload across PRWCC PIs, data managers and research staff.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. Develop infrastructure for PRWCC to serve as resource for clinical advice (practitioners and patients) and advance web-based interface for the PRWCC where practitioners can seek PRWCC information and clinical advice.
• Oversee PRWCC research activities and working group structure and activities and assure there is limited overlap in parallel working groups. Ensure working groups and PRWCC members engaged in research projects have the resources, data and support required to permit successful research execution.
• Performs related duties & responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience required; plus, three years of related experience.

Preferred Qualifications

• Knowledge of the clinical research process and research regulatory processes, regulations and procedures.
• Ability to produce Gantt Charts for project management
• Firm understanding of the research process including but not limited to; the development of protocol, implementation of a successful research project, and management of RA’s using project plans and coordinating teamwork assignments in the field
• 5 or more years of relevant work experience – i.e., in clinical research, device development, pharmaceutical industry etc.
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Demonstrated project management ability to employ integration, scope time management, cost, quality, human resources, communications, risk, and procurement components.
• Ability to balance expectations with project reality.
• Demonstrated resilience, diplomacy, influence, relationship building, and problem-solving skills in a variety of situations.