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Platform:
Work from Office
Full Time
Lead the planning, initiation, execution, and close-out of global clinical trials, ensuring adherence to regulatory guidelines, Good Clinical Practice (GCP), and internal quality standards.
Develop and manage detailed trial timelines, budgets, and resource plans, ensuring alignment with overall program objectives.
Collaborate with cross-functional teams including clinical operations, data management, biostatistics, regulatory affairs, and safety to ensure trial deliverables are met.
Oversee site selection, initiation, and performance, ensuring robust recruitment strategies and high-quality data collection.
Monitor trial progress through regular status updates, risk assessments, and issue resolution, escalating concerns to stakeholders as needed.
Ensure compliance with ethical standards and local/global regulations across all participating countries.
Manage relationships with CROs, vendors, and investigative sites, ensuring contractual and performance expectations are met.
Lead trial team meetings, provide clear communication of project goals, and ensure accountability for deliverables.
Prepare and review key trial documents, including protocols, informed consent forms, monitoring plans, and final study reports.
Foster a culture of continuous improvement, capturing lessons learned and applying them to future trials for efficiency and quality enhancement.
Bristol Myers Squibb
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