Clinical Data Manager

Responsibilities

• Manage and facilitate clinical data review, data cleaning, and discrepancy resolution to ensure high-quality study deliverables
• Review study protocols and relevant data review documents, such as Protocol Data Review Plans and Data Quality Management Plans
• Perform data cleaning according to defined Clean Patient Groups and manage the freezing and locking of CRFs/Fields
• Coordinate with Data Management Leads regarding study deliverables
• Complete comprehensive reviews of loaded external data and track data loads
• Coordinate with external data vendors to resolve data discrepancies
• Maintain appropriate documentation filing within the eTMF as per the master plan

Requirements

• Bachelor's Degree in Life Sciences, Pharmacy, or a relevant field
• At least 2 years of experience in Clinical Data Review tasks
• Basic knowledge of the Clinical Drug Development Process and FDA/ICH guidelines
• Proficiency in EDC systems, with Medidata RAVE preferred
• Strong Microsoft Office skills
• Excellent oral and written communication skills
• Ability to work collaboratively within multi-disciplinary project teams

About the Company

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail against serious diseases. We foster a culture of passion, innovation, and integrity, providing employees with unique opportunities to grow and transform lives through science.