Clinical Study Manager I: Translational Research

Rutgers University; New Brunswick (NJ); Hybrid; USD 76,000 - 109,000; Full time

Benefits offered by this job

Medical coverage

Paid vacation and leave programs

Retirement benefits

Educational benefits

Life insurance

Employee discount programs

Job summary

Rutgers University seeks a CRC (RCRC Clinical Study Manager I) to lead operational aspects of multicenter clinical and translational studies within the Rutgers Contract Research Collaboratory Center (RCRC) at RITMS. This role coordinates investigators, sponsors, sites, and vendors to ensure quality, timelines, and compliance throughout the study lifecycle.

The ideal candidate will bring at least five years of relevant experience, strong communication, risk management, and trial master file

Qualifications

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

Responsibilities

• Serves as the primary day-to-day operational resource for assigned clinical and translational research studies.
• Independently manages study timelines, milestones, risks, deliverables, and operational activities.
• Coordinates communication and collaboration among investigators, sponsors, sites, vendors, and internal teams.
• Identifies operational risks and develops mitigation strategies to support successful study execution.
• Monitors study performance and proactively address issues affecting timelines, quality, compliance, or operational objectives.
• Facilitates study team meetings and drives accountability for assigned action items and deliverables.
• Ensures study activities comply with applicable regulatory requirements, organizational standards, and best practices.
• Supports study reporting, closeout, and lessons learned activities.
• Contributes to onboarding, mentoring, knowledge sharing, and continuous improvement initiatives.
• Ensures eTMF completeness, quality, and inspection/audit readiness for assigned studies.

Skills

GCP knowledge

Stakeholder management

Regulatory compliance

TMF/eTMF familiarity

Communication

Education

Bachelor's degree in a related field

Tools

Project management tools

Clinical research systems

Job description

Rutgers University seeks a CRC (RCRC Clinical Study Manager I) to lead operational aspects of multicenter clinical and translational studies within the Rutgers Contract Research Collaboratory Center (RCRC) at RITMS. This role coordinates investigators, sponsors, sites, and vendors to ensure quality, timelines, and compliance throughout the study lifecycle.

The ideal candidate will bring at least five years of relevant experience, strong communication, risk management, and trial master file