Clinical Data Manager

Summary:  

The Clinical Data Manager will be responsible for managing and overseeing the collection, validation, and analysis of clinical trial data. They will also be responsible for ensuring the quality and accuracy of the data throughout the entire trial process. 

Responsibilities: 

• Develop and implement data management plans and procedures for clinical trials 
• Oversee the collection and validation of clinical trial data 
• Ensure data quality and accuracy through data review, query resolution, and data cleaning 
• Work with cross-functional teams, including biostatistics, clinical operations, and medical writing 
• Ensure compliance with regulatory and industry standards 
• Participate in the development of clinical study protocols and case report forms 
• Manage data transfer and reconciliation between different systems 
• Generate study-specific data management reports 
• Provide input into the development of project timelines and resource planning 
• Maintain knowledge of relevant industry and regulatory guidelines 
• Develop and maintain data management standards and best practices 

Qualifications: 

• Bachelor's degree in a life science or related field 
• Minimum of 3 years of experience as a Clinical Data Manager in the biopharmaceutical industry 
• Familiarity with CDISC standards and guidelines 
• Knowledge of clinical trial design and statistical analysis 
• Experience with Electronic Data Capture (EDC) systems 
• Knowledge of regulatory guidelines, including FDA and ICH guidelines 
• Excellent analytical and problem-solving skills 
• Strong written and verbal communication skills 
• Ability to work independently as well as in a team environment 
• Strong attention to detail and accuracy