Clinical Study Manager I: Research Operations Lead

Rutgers University; New Brunswick (NJ); Hybrid; USD 79,000 - 121,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

Retirement benefits

Educational benefits

Life insurance

Employee discounts

Job summary

Rutgers University in New Brunswick, NJ, seeks an experienced Clinical Study Manager I to lead operational delivery of multi-site clinical and translational research studies within the Rutgers Contract Research Collaboratory (RCRC). You will coordinate investigators, sponsors, sites, vendors, and data managers throughout study lifecycle.

The role emphasizes start-up through closeout, risk management, timelines, and regulatory compliance, with hybrid work options.

Qualifications

• Bachelor’s degree in clinical research, health sciences, or related field.
• Minimum five years of relevant clinical research or project management experience.
• One year of Clinical Study Manager experience required.
• Knowledge of GCP, regulations, and TMF/eTMF systems.
• Experience managing multicenter trials and sponsors.
• Experience with risk mitigation and study oversight.
• Clinical Research Professional certification preferred.
• Experience in academic medical centers, CROs, pharma.

Responsibilities

• Manage operational execution of assigned studies from start-up through closeout and reporting.
• Serve as the primary day-to-day operational lead for assigned studies.
• Collaborate with investigators, sponsors, sites, vendors, biostatisticians, data managers, regulatory personnel, and others.
• Develop and maintain study timelines, plans, risk registers, and communication tools.
• Facilitate study team meetings and ensure timely deliverables.

Skills

GCP knowledge

Stakeholder management

Communication

Attention to detail

Project management

Multicenter trials

Education

Bachelor's degree in Clinical Research, Health Sciences, Public Health, Nursing, Biological Sciences, Healthcare Administration, Business Administration, or related field

Job description

Rutgers University in New Brunswick, NJ, seeks an experienced Clinical Study Manager I to lead operational delivery of multi-site clinical and translational research studies within the Rutgers Contract Research Collaboratory (RCRC). You will coordinate investigators, sponsors, sites, vendors, and data managers throughout study lifecycle.

The role emphasizes start-up through closeout, risk management, timelines, and regulatory compliance, with hybrid work options.