Global Clinical Trial Lead — Rare Disease

Meet Life Sciences Ltd.; Bridgewater Township (NJ); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Meet Life Sciences Ltd. in New Jersey, USA, seeks a Senior Clinical Trial Manager/Clinical Operations Lead to oversee global trial activities from planning to close-out.

You will lead cross-functional study teams, ensure ICH/GCP compliance, manage timelines and budgets, and coordinate with CROs and external vendors to deliver high-quality results.

The role emphasizes complex studies, collaboration across functions, and a focus on patient outcomes within a regulated biopharmaceutical environment.

Formación

• 7+ years of clinical trial management experience in pharma/biotech.
• Experience leading global, large-scale trials.
• Strong knowledge of ICH/GCP and regulatory requirements.
• Experience working with CROs and external vendors.
• Proven ability to manage study documents, timelines, and reporting.

Responsabilidades

• Lead and coordinate global/regional clinical trial activities in compliance with ICH/GCP and regulatory requirements
• Oversee trial execution, including site feasibility, activation, enrollment, monitoring, and study milestones
• Lead cross-functional study teams and drive deliverables on time, within budget, and to high quality standards
• Develop and manage clinical trial plans, study documentation, timelines, and status reporting
• Partner closely with CROs and external vendors, managing performance, milestones, risks, and contractual deliverables
• Support development and review of protocols, amendments, CRFs, informed consent forms, study plans, and training materials
• Drive resolution of site, protocol, safety, data, and operational issues
• Participate in risk-based quality management and risk-based monitoring activities
• Collaborate with Data Management and clinical teams to support database lock and data review milestones
• Maintain strong inspection readiness, including oversight of Trial Master File documentation
• Support investigator meetings, CRO meetings, monitoring training, and investigator engagement activities
• Bachelor's degree preferred in Life Sciences, Healthcare, or a related field

Conocimientos

Clinical Trial Management

Global Clinical Operations

CRO Management

Regulatory Compliance

Budget Management

Cross-functional Leadership

Educación

Bachelor's degree in Life Sciences, Healthcare, or related field

Descripción del empleo

Meet Life Sciences Ltd. in New Jersey, USA, seeks a Senior Clinical Trial Manager/Clinical Operations Lead to oversee global trial activities from planning to close-out.

You will lead cross-functional study teams, ensure ICH/GCP compliance, manage timelines and budgets, and coordinate with CROs and external vendors to deliver high-quality results.

The role emphasizes complex studies, collaboration across functions, and a focus on patient outcomes within a regulated biopharmaceutical environment.