Senior Clinical Data Manager

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 5 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