Senior Clinical Data Manager

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – e...

As a Senior Clinical Data Manager, you will play a critical role in supporting clinical development programs across the Dianthus portfolio, driving data quality and operational excellence throughout the clinical trial lifecycle.

You will oversee all clinical data management activities and deliverables from study start-up through database lock and closeout across multiple clinical trials. Working independently with cross-functional teams and external partners, you will ensure the delivery of complete, accurate, high-quality, and regulatory-c...

We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Responsible for relationships with Data Management partners (eg, CROs and vendors)
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
Represent DM during Investigator Meetings, CRA training, on-site visits, company or department meeting
Bachelors degree in life sciences required
Minimum of 5 years of clinical data management experience in Sponsor and/or CRO setting
Strong understanding of DM related systems, technologies and standards including data analytics platforms
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 take direction and work within a high-functioning and collaborative team environment
Detail-oriented with strong verbal and written communication skills
Ability to build relationships internally and with external partners
Highest levels of professionalism, confidence, personal values and ethical standards