Multi-Center Clinical Trials Manager

Position Summary

The Multi-Center Clinical Trials Manager will be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). The candidate is responsible for providing managerial oversight for CUMC sponsored multicenter trials including protocol development, site activations, data management, regulatory processing, auditing/monitoring, specimen collection, data analysis and publication. Assist in the development of multicenter clinical trial budgets, sub-site invoicing/payments and research fund accounting. Help facilitate multicenter trials confidentiality disclosure agreements and clinical trial contracts. The candidate is responsible for implementing policies and procedures that improve and stimulate the work environment, which is a key aspect of this position. The candidate is responsible for assessing workloads, competently, and assigning projects appropriately to ensure positive outcomes. The candidate must recognize and identify opportunities for continued improvement and operational efficiencies. In addition, the reputation of the institution relies on the quality of the clinical research team; this reputation in turn ensures continued positive relationships with private industry and other external agencies.

This position reports to the Assistant Director, Clinical Research Operations and is primarily based out of 400 Kelby Street, Fort Lee, NJ.

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

Responsibilities

• Coordinating the Multi-Center Trials Operational activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Multi-Center Coordinators; creating and promoting professional development opportunities (both internally and externally) for staff; Implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies; assists the departmental finance administrator in maintaining accurate and up-to-date invoice statuses/payments across MCT trials.
• Posts/justifies new and replacement positions, screens applicants, on-boards and trains staff (protocol, university, departmental training). Liaises with the HICCC HR representative for scheduling of HR-related functions. Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals).
• Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations. Determines workloads and protocol assignments. Develops quality control mechanisms to ensure accurate regulatory submission practices on behalf of the department. Assists with IND management/submission/oversight on behalf of all applicable Sponsor-Investigator held MCT INDs.
• Provides MCT protocol management and research/regulatory expertise by participating in discussions pertinent to projects at collaborative research meetings. Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks. Attends regularly scheduled conferences and meetings.
• Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs). Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
• Collaborates with all members of the office with special attention to compliance and monitoring of MCT portfolio.
• Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.
• Collaborates with investigators to develop multicenter protocols including budget development.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's Degree or equivalent plus four years of related experience.

Preferred Qualifications

• At least one year of supervisory experience. Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
• Excellent interpersonal and organizational skills.
• Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
• Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.