Senior Clinical Data Manager

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as a Senior Clinical Data Manager. You will play a critical role in overseeing clinical data management for our Myasthenia Gravis program and other trials. Responsibilities include managing relationships with data management partners, overseeing outsourced activities, ensuring data quality and timeliness, and maintaining data integrity. This position requires a university degree in a relevant discipline, comprehensive understanding of DM systems and standards, and knowledge of drug development and GCP guidelines. The company offers remote work flexibility and is building a culture centered around patient care.

Requirements

• University degree required within a relevant discipline
• 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

• Responsible for 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
• Other related duties as may be determined or assigned

Preferred Qualifications

Life Sciences experience is a plus

Benefits

We are open to you working remotely