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Role & Responsibilities
• Lead and implement clinical trial activities as Clinical Trial Lead for one or more trials
• Manage interactions with local health authorities and Subject Expert Committees
• Plan, execute, and oversee study startup, conduct, and close-out activities
• Develop and review protocols, informed consent forms (ICFs), and clinical quality documents
• Supervise clinical data generation and validation, including CRF design and query resolution
• Contribute to clinical development planning and provide medical insights for future trials
• Support risk management plans (RMPs) and conduct signal detection activities
• Provide leadership and guidance to a team of supporting Clinical Scientists
Qualification
• Medical qualification (MD in Pharmacology, Oncology, or Hematology preferred)
Experience
• 10+ years of experience in clinical science or clinical research
• Experience in leading scientific interactions with DCGI and Subject Expert Committees
• Oncology and Hematology therapeutic areas experience preferred
Skills
• Strong understanding of GCP/ICH guidelines, drug development processes, and study design
• Ability to analyze clinical data trends and support program-specific data review
• Proficient communication, problem-solving, and critical thinking skills
• Strong planning and project management skills, with an ability to work effectively under pressure
• Proficient in Microsoft Word, Excel, PowerPoint, and data reporting tools (e.g., RAVE)
About the Company
• Bristol Myers Squibb is a global biopharmaceutical leader, committed to advancing patients' lives through innovative science and cutting-edge therapies in oncology, immunology, cardiovascular disease, and fibrosis.