Sr. Clinical Data Manager

Sr. Clinical Data Manager role at Katalyst CRO

• Lead clinical data management activities for pivotal trials, ensuring data quality and integrity
• Collaborate with cross-functional teams to support clinical trial data management processes
• Oversee vendor management and ensure compliance with regulatory standards
• Drive development and implementation of data management plans and validation activities
• Coordinate data cleaning and reporting activities to meet project goals
• Support database design, validation, and maintenance for clinical trials
• Ensure adherence to Good Clinical Practice (GCP) and regulatory requirements
• Provide leadership and guidance to data management teams and stakeholders
• Act as Data Management Study Lead for multiple clinical trials
• Manage vendor relationships and ensure timely delivery of data management services
• Develop and maintain critical data management documentation and plans
• Coordinate data transfer setups and validations, ensuring consistency with agreements
• Perform supplemental data reviews and quality checks as per validation specifications
• Participate in study document reviews, including protocols and statistical analysis plans
• Ensure compliance with CDISC standards and clinical research regulations
• Report project status and escalated study-related issues to senior leadership

• Bachelor of Science degree with 10+ years of clinical data management experience
• Proficiency in EDC systems, CDISC standards, and clinical research regulations
• Experience managing multiple CROs/vendors and ensuring data quality
• Strong knowledge of database structures and data visualization technologies
• Excellent interpersonal, organizational, and communication skills
• Ability to prioritize tasks and work effectively in a fast-paced environment
• Logical thinking and attention to detail for high-quality data management
• Commitment to maintaining compliance with GCP and regulatory standards.