Senior Clinical Data Manager

About the Company

Dianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. Their lead antibody, claseprubart, is engineered for improved potency and selectivity to enable convenient self-administered subcutaneous injections.

Responsibilities

• Manage relationships with Data Management partners including CROs and vendors
• Oversee outsourced study-related DM activities such as CRF design, data collection, edit checks, and listings reviews
• Manage data reconciliation for SAEs, labs, and other external data
• Oversee medical coding, UAT testing, database lock, and archival of DM documents
• Ensure data quality and timeliness of DM deliverables align with company goals
• Maintain data integrity in compliance with GCP, SOPs, and regulatory requirements
• Represent DM during Investigator Meetings, CRA training, and on-site visits

Requirements

• Bachelor's degree in life sciences
• Minimum of 5 years of clinical data management experience in a Sponsor and/or CRO setting
• Strong understanding of DM related systems, technologies, and standards
• Comprehensive knowledge of drug development, clinical research processes, and GCP guidelines
• Strong verbal and written communication skills
• Ability to work autonomously and collaboratively