Clinical Trial Operations Lead: Cross-Functional Delivery

Meet Life Sciences Ltd.

Bridgewater Township (NJ)

On-site

USD 110,000 - 160,000

Full time

27 hours ago
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Job summary

Meet Life Sciences Ltd. in New Jersey is seeking an experienced clinical trial professional to manage and execute studies in collaboration with Clinical Operations leadership. You will ensure trials comply with GCP, regulatory requirements, and study timelines and budgets.

The role emphasizes CRO/vendor oversight, RBQM, risk-based monitoring, data review, and inspection readiness, with opportunities to lead multi-regional trials and mentor junior staff.

Qualifications

  • Minimum 5 years of clinical trial management experience in pharma/biotech.
  • Solid understanding of ICH/GCP and local regulations.
  • Experience managing CROs and external vendors.
  • Ability to coordinate cross-functional study teams and manage competing priorities.

Responsibilities

  • Support planning, management, and execution of clinical trial activities per ICH/GCP and guidelines.
  • Coordinate cross-functional study team activities to ensure on-time and within-budget deliverables.
  • Oversee regional trial activities and monitor site-level progress of studies.
  • Address protocol compliance, patient safety, data quality, and site issues with action plans.
  • Develop and review study documentation, CRFs, informed consent, and manuals.
  • Collaborate on site feasibility with Clinical Development, Medical Affairs, and Clinical Operations.
  • Engage with Medical Liaisons for investigator engagement and meetings.

Skills

Clinical trial management
ICH/GCP knowledge
CRO/vendor oversight
Cross-functional coordination
Site oversight
RBQM
Data review
Investigator meetings
Project milestones
Documentation
Patient safety

Education

Bachelor's degree in life sciences

Job description

Meet Life Sciences Ltd. in New Jersey is seeking an experienced clinical trial professional to manage and execute studies in collaboration with Clinical Operations leadership. You will ensure trials comply with GCP, regulatory requirements, and study timelines and budgets.

The role emphasizes CRO/vendor oversight, RBQM, risk-based monitoring, data review, and inspection readiness, with opportunities to lead multi-regional trials and mentor junior staff.

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