Senior Clinical Trial Manager

?? 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

?? What We're Looking For:

• 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

?? Ideal Background:

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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