Clinical Trial Manager

Responsibilities

• Provide end-to-end study operational oversight and delivery at the country level, ensuring adherence to timelines, budget, and quality standards
• Act as the primary point of contact for internal and external stakeholders at the country level to ensure effective coordination and project execution
• Implement local country and site feasibility processes, including the validation of study targets
• Plan and execute timelines for study start-up in collaboration with local study teams and the Global Trial Acceleration Centre (GTAC)
• Implement country and site-level patient recruitment strategies and manage risk mitigation efforts
• Lead problem-solving efforts, including risk management, issue resolution, and escalation to appropriate stakeholders
• Manage vendor assessment and setup during the study start-up period
• Ensure data integrity within the Clinical Trial Management System (CTMS) and maintain completeness of the eTMF
• Support the review and preparation of country and site-specific documents, such as Informed Consent Forms (ICF) and patient materials
• Ensure inspection readiness and provide support for Health Authority inspections and pre-inspection activities
• Coordinate Corrective Actions / Preventive Actions (CAPA) for country audit-level findings

Requirements

• Bachelor's or Master's degree in life sciences or an equivalent field
• Minimum of 4 years of industry-related experience in clinical trials
• Thorough understanding of GCP and ICH Guidelines
• In-depth knowledge of clinical research processes, regulations, and methodology
• Strong organizational, time management, and critical thinking skills
• Excellent verbal and written communication skills in English and the local language
• Proficiency in using CTMS, eDC, and eTMF systems

About the Company

Bristol Myers Squibb is a global biopharmaceutical company that seeks to discover, develop, and deliver innovative medicines that help patients prevail against serious diseases. We offer a collaborative environment where uniquely interesting work happens every day, transforming the lives of patients and the careers of those who do it.