Senior Clinical Data Manager

Qualifications 

• Bachelor's degree in life science/related field, advanced degree preferred
• Minimum of 5+ years of experience in clinical data management, with at least 3+ years in a leadership or senior role
• In-depth knowledge of clinical trial processes, data management methodologies, and regulatory requirements
• Proficiency in data management software 
• Strong leadership capabilities with a proactive and adaptable approach.
• Ability to work effectively under pressure and manage multiple priorities.

Responsibilities 

• Lead and manage the clinical data management activities for assigned clinical trials or projects.
• Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to ensure data integrity and quality.
• Develop data management plans (DMPs) and oversee their implementation to ensure efficient data collection, validation, and cleaning.
• Define and implement data validation checks and edit checks to maintain data quality.
• Perform data review and validation activities to ensure accuracy and completeness of clinical trial data.
• Generate and review data listings, summary tables, and data visualizations for clinical study reports.
• Ensure adherence to relevant regulatory guidelines (e.g., FDA, ICH GCP) and industry standards for clinical data management.
• Implement and maintain SOPs related to clinical data management processes.
• Provide mentorship and leadership to junior data management staff.
• Conduct training sessions on data management processes and systems for team members and stakeholders.
• Evaluate and recommend new data management technologies and tools to enhance efficiency and quality.
• Stay updated with industry trends and best practices in clinical data management.
• Act as a key point of contact for data management issues and queries from internal and external stakeholders.
• Facilitate data management meetings and contribute to cross-functional project teams.