Clinical Research Manager

Columbia University Irving Medical Center; New York (NY); Hybrid; USD 100,000 - 110,000; Full time

Job summary

Columbia University Irving Medical Center's CPDM Office seeks a Clinical Research Manager to join its senior leadership team, overseeing data management coordination and supervision of CRCs, DCs, and staff, ensuring safety and excellence in trials.

You will lead staffing, protocol management, finance oversight, staff development, and collaboration with disease teams, investigators, and regulatory staff to ensure timely study start-up and conduct.

Qualifications

• Bachelor’s degree or equivalent in education, training and experience, plus 4 years of related experience.
• Minimum one year of supervisory experience.
• Experience in clinical research, including ICH-GCP and CFR guidelines.

Responsibilities

• Posts/justifies new and replacement positions, screens applicants.
• On-boards and trains staff (protocol, university, departmental training).
• Liaises with HR for scheduling medical surveillance, JCAHO, and HR-related functions.
• Makes salary recommendations for staff and conducts annual performance reviews.
• Directs and supervises staff to maintain efficient operations.
• Manages protocol/disease-base team activities and feasibility assessments.
• Coordinates multidisciplinary meetings to ensure timely study start-up and conduct.
• Prepares and monitors study budgets and analyzes variances.
• Develops SOPs and standard forms for CPDM.

Skills

Staff supervision

Budget management

Clinical research

Regulatory knowledge

Education

Bachelor’s degree or equivalent

Tools

MS Office

Job description

Grade 105

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $100,000 - $110,000

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 candidate 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). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs), Data Coordinators(DCs), Research Study Assistants and other staff as assigned; 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. The Clinical Research Manager reports directly to the Assistant Director, Clinical Research Operations.

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.

PROTOCOL/ DISEASE BASE 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 ongoing assessment of trials 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.
• 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

• Perform other related duties and responsibilities as assigned/requested.

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).

Equal Opportunity Employer / Disability / Veteran

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