Clinical Trial Operations Lead: Cross-Functional Delivery

Meet Life Sciences Ltd.; Bridgewater Township (NJ); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical trial management

ICH/GCP knowledge

CRO/vendor oversight

Cross-functional coordination

Site oversight

RBQM

Data review

Investigator meetings

Project milestones

Documentation

Patient safety

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

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.