Senior Clinical Data Manager

Responsibilities

• Review clinical protocols and relevant study-specific data review documents
• Provide input for key documents including Protocol Data Review Plans and Data Quality Management Plans
• Review clinical data listings and prioritize critical data review tasks
• Manage and facilitate the resolution of data discrepancies
• Perform data cleaning according to defined Clean Patient Group standards
• Manage the freezing and locking of CRFs and data fields
• Track external data loads and address any resulting discrepancies
• Complete reviews of loaded external data, prioritizing complex reviews such as Biomarker, SAE, or Blinded Independent Committee Review
• Coordinate with external data vendors to resolve discrepancies
• Ensure appropriate documentation is filed in the eTMF as per the master plan
• Provide training and mentorship to junior Clinical Data Management staff

Requirements

• Proven experience in clinical data management and data cleaning
• Strong expertise in protocol review and data discrepancy resolution
• Experience tracking and reviewing external data loads
• Ability to provide mentorship and training to junior team members
• Proficiency in managing study deliverables and coordinating with data management leads

About the Company

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We foster a culture of passion, innovation, and integrity to transform patients' lives through science.