Clinical Research Manager

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Clinical Research Manager is a key member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). This role oversees Research Study Assistants, and other staff, while leading biospecimen recruitment and collection efforts to support clinical and translational research. The Manager ensures proper patient identification, consent, specimen handling and documentation, and collaborates with investigators and labs to align biospecimen workflows with research protocols. Additionally, the role supports the development and maintenance of research databases to enhance data integration and accessibility, while promoting staff development, streamlining operational processes, optimizing resource allocation, and fostering strong relationships with industry and external partners. The position reports to the Assistant Director.

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

Responsibilities

STAFFING

• 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 medical surveillance, JCAHO, and other 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)

SUPERVISION

• Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations.
• Determines staff workloads and protocol assignments.
• Assures the subject data collected by the staff is organized and submitted in a timely manner.
• Develops quality control mechanisms to ensure accurate data reporting.
• Assists with CRF development, accuracy, and implementation for investigator-initiated trials.
• Ensures staff are adequately prepared for and successfully manage all monitoring and / or auditing visits.

TEAM MANAGEMENT

• Provides protocol management and research expertise by actively participating in discussions at disease team and collaborative research meetings, ensuring operational feasibility, compliance, and strategic alignment with CPDM and Cancer Center goals.
• Leads biobanking efforts and complex collections
• Leads ongoing assessment of clinical research studies within the portfolio to evaluate feasibility, accrual trends, and resource utilization. Implements priority scoring and portfolio review processes to ensure staffing and support are aligned with institutional priorities and study performance.
• Organizes and coordinates project activities, collaborating with multidisciplinary teams-including investigators, research nurses, coordinators, and regulatory staff-to ensure timely completion of study start-up, activation, and conduct.
• Oversee data request services for research studies, coordinating with HICCC Clinical Informatics, Molecular Pathology, and Biostatistics Shared Resources to process requests, extract, collate and merge data, and disseminate to investigators
• Represents the department at conferences and meetings, maintaining effective communication channels between clinical, research, and administrative stakeholders to promote consistent study management, issue resolution, and operational best practices.

FINANCE MANAGEMENT

• Prepares and reviews study budgets for submission, negotiation, and ongoing financial monitoring to ensure accuracy, compliance, and alignment with departmental standards.
• Monitors, reports, and interprets variances to approved budgets. Collaborates with the Assistant Director to develop and execute action plans that address financial gaps and optimize resource utilization. Uses forecasting tools to project financial outcomes and proactively identify risks and opportunities.
• Implements strategies to support financial stability and operational efficiency across assigned studies and departmental functions. Ensures financial practices align with institutional priorities, long-term sustainability goals, and portfolio management objectives.

DEPARTMENT INITIATIVES

• 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

OTHER

• Performs other related duties as assigned.

Minimum Qualifications

• Bachelor's Degree or equivalent in education, training and experience, plus 4 years of related experience

Preferred Qualifications

• Certification as a Clinical Research Professional through a national accrediting body such as ACRP and / or SoCRA.

Other Requirements

Minimum 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), electronic data collection tools (e.g., REDCap) and statistical software (e.g., SAS, R, STATA).

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.