About Us
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 – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit
www.dianthustx.com and follow us on
LinkedIn.
About the Role
As a Senior Clinical Data Manager, you will play a critical role within the team leading our data management processes for our Multifocal Motor Neuropathy (MMN) phase II study and supporting our ongoing Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) phase III study.
Reporting to the Director of Data Sciences, you will be responsible for overseeing all clinical data management and related deliverables from start-up through close out of various clinical trials. This individual will independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data in support of study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to support data aggregation and analysis in the advancement of patient care.
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.
Key Responsibilities
- 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 meetings.
- Other related duties as may be determined or assigned.
Experience
- BS in relevant discipline. Life Sciences experience is a plus.
- 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.
