Hybrid Clinical Study Manager I — Research Operations

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

Benefits offered by this job

Medical, prescription drug, and dental

Paid vacation and holidays

Retirement benefits

Educational benefits

Job summary

Rutgers University is seeking a CRC (RCRC Clinical Study Manager I) to lead day-to-day operational management of clinical studies within the Rutgers Contract Research Collaboratory. The role collaborates with investigators, sponsors, sites, vendors, and internal teams to ensure quality execution from planning through reporting.

The position requires a Bachelor’s degree and at least five years of clinical research or related operations experience, with a strong focus on risk management, TMF/eTMF

Qualifications

• Bachelor’s degree in a health science or related field as required.
• Minimum five years of clinical research, project management, study coordination, or research operations experience.
• Ability to independently manage clinical studies or complex project workstreams.
• Familiarity with Trial Master File (TMF) or electronic TMF (eTMF) systems.
• Experience with multicenter clinical trials or complex clinical research programs preferred.

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

Independent study management

GCP knowledge

Verbal & written communication

Stakeholder coordination

Education

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

Tools

TMF/eTMF systems

Job description

Rutgers University is seeking a CRC (RCRC Clinical Study Manager I) to lead day-to-day operational management of clinical studies within the Rutgers Contract Research Collaboratory. The role collaborates with investigators, sponsors, sites, vendors, and internal teams to ensure quality execution from planning through reporting.

The position requires a Bachelor’s degree and at least five years of clinical research or related operations experience, with a strong focus on risk management, TMF/eTMF