Clinical Research Manager
Columbia University Irving Medical Center · New York, NY · 2 wk ago
Analyst$100k–$110k/yrFull-time
Grade 105 | Regular, full-time position (35 hours per week)
About the role
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). Subject to business needs, flexible and hybrid work arrangements may be supported.
Responsibilities
- Staffing
- Posts and 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 to facilitate efficient operations
- Determines staff workloads and protocol assignments
- Ensures subject data collected by 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 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 align staffing and support 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
- 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 addressing financial gaps and optimizing 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
- Department Initiatives
- Assists the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs)
- Develops standardized forms, study tools, and promotes cross-coverage with CPDM Leadership
- Performs other related duties and responsibilities as assigned or requested
Requirements
- Bachelor’s degree or equivalent in education, training, and experience, plus 4 years of related experience
- Minimum one year of supervisory experience
- Experience in a clinical research setting, including a thorough understanding of ICH-GCP and CFR guidelines
- Excellent interpersonal and organizational skills
- Proficiency with MS Office products (Word, Excel, PowerPoint)
Preferred Qualifications
- Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA
Pay
$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.