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Role & Responsibilities
• Review clinical trial protocols and data review plans
• Prepare and contribute to Data Quality Management Plans
• Perform detailed review of clinical data listings and prioritize critical data
• Manage query generation, resolution and data cleaning activities
• Execute CRF freezing and database lock activities
• Track and review external data loads including SAE, biomarker and adjudication data
• Liaise with external vendors for discrepancy resolution
• File essential documents in eTMF in line with master plan requirements
• Ensure compliance with FDA, ICH and global data management standards
• Train and mentor junior Clinical Data Management team members
• Collaborate with cross-functional clinical teams to meet study timelines
Qualification
• Bachelor’s degree in Life Sciences, Pharmacy or related discipline
Experience
• Minimum 4 years of experience in clinical data review and management
Skills
• Strong knowledge of clinical drug development process
• Hands-on experience with EDC systems (Medidata RAVE preferred)
• Proficiency in Microsoft Office tools
• Excellent written and verbal communication skills
• Strong analytical, coordination and problem-solving abilities
• Ability to work collaboratively in cross-functional environments
About the Company
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader focused on discovering, developing and delivering innovative medicines that help patients prevail over serious diseases, offering professionals a collaborative, ethical and patient-centered work culture with strong career growth opportunities.