Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative therapies for patients with severe autoimmune diseases. As a Senior Clinical Data Manager, you will play a pivotal role in supporting our clinical development programs by ensuring data quality and operational excellence throughout the entire lifecycle of our clinical trials.
Key responsibilities
- Manage relationships with external Data Management partners, including CROs and various vendors.
- Oversee outsourced study-related activities such as CRF design, data collection, edit checks, medical coding, and UAT testing.
- Ensure the delivery of high-quality, accurate, and timely data that aligns with company goals and regulatory standards.
- Maintain data integrity in compliance with GCP guidelines and internal SOPs, ensuring proper documentation in the Trial Master File.
- Represent the Data Management function during investigator meetings, training sessions, and cross-functional team collaborations.
Requirements
- Bachelor’s degree in life sciences.
- Minimum of 5 years of experience in clinical data management within a sponsor or CRO environment.
- Strong technical proficiency with DM systems, data analytics platforms, and industry standards.
- Comprehensive knowledge of drug development processes, GCP guidelines, and regulatory requirements.
- Excellent communication skills with the ability to work autonomously and collaboratively in a fast-paced environment.
What we offer
- Opportunity to contribute to the development of potentially best-in-class therapies for autoimmune diseases.
- A culture centered on core principles and a commitment to elevating patient care.
- A fully remote work environment that supports professional autonomy and high-functioning teamwork.