Senior Clinical Trial Manager

Meet Life Sciences; Bridgewater Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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

Skills

Clinical Trial Management

Global Clinical Operations

CRO Management

Regulatory Compliance

Budget Management

Cross-functional Leadership

Education

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

Job description

Senior Clinical Trial Manager / Clinical Operations Lead

Are you an experienced Clinical Trial Manager with a strong background in global clinical operations and complex studies? I'm currently looking to connect with senior clinical research professionals who have experience leading trials from planning through close-out.

This is an exciting opportunity to join a growing biopharmaceutical organization focused on advancing therapies for patients with significant unmet medical needs.

What You'll Be Doing:

• 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
• 7+ years of clinical trial management experience within the pharmaceutical or biotechnology industry
• Experience managing global, large-scale, complex, and/or early-phase clinical trials
• Experience working with rare disease and/or orphan indications strongly preferred
• Proven experience managing global CROs and specialty vendors
• Strong understanding of the drug development process, ICH/GCP, and applicable regulations
• Experience providing indirect leadership, coaching, mentoring, and influencing cross-functional teams
• Strong ability to operate within a matrixed environment and independently drive projects forward
• Excellent communication, organization, critical thinking, problem-solving, and conflict-resolution skills
• Bachelor's degree preferred in Life Sciences, Healthcare, or a related field

Clinical Operations | Clinical Trial Management | CRO Management | Global Studies | Rare Disease | Orphan Indications | GCP | RBQM | RBM | Site Management | Vendor Management | Biotech | Pharmaceutical

If you're a Senior Clinical Trial Manager, Clinical Operations Lead, or experienced clinical operations professional open to hearing about a new opportunity, I'd love to connect and share more details.

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