Dianthus Therapeutics is hiring a
Senior Clinical Data Manager, Remote - Worldwide

Summary

The job is for a Senior Clinical Data Manager at Dianthus Therapeutics, a biotech company dedicated to designing and delivering novel antibodies. The role involves overseeing clinical data management for various trials, ensuring high-quality, regulatory compliant data, and working with partners. Remote work is allowed.

Requirements

• University degree required within a relevant discipline – Life Sciences experience is a plus
• Comprehensive understanding of DM related systems, technologies and standards
• Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management
• Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment
• Highly organized and detail-oriented
• Strong verbal and written communication skills with the ability to build relationships internally and with external partners
• Highest levels of professionalism, confidence, personal values and ethical standards

Responsibilities

• Oversee all clinical data management and related deliverables from start-up through close out of various clinical trials
• Maintain relationships with Data Management partners (eg, CROs and vendors) from protocol development through database lock to ensure data are collected, reviewed and delivered with high quality, are on-time and within scope
• Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation (SAEs, labs, other external data), medical coding, UAT testing, database lock and archival of DM documents
• Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals
• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File

Benefits

The company is open to remote work