Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Senior Clinical Data Manager, you will have play a critical role within the team.
Reporting to the Director, Data Management, 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) 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
Experience
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Technology, Information and Internet
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