Dianthus Therapeutics is hiring a Remote Senior Clinical Data Manager
\nAbout Us\nDianthus 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.\n\n\nAbout the Role\n\nAs the Senior Clinical Data Manager, you will have play a critical role within the team.\n\nReporting 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.\n\nWe 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 patientsโ lives. We are open to you working remotely.\n\nKey Responsibilities\n\n\n* 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.\n\n* 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.\n\n* Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals\n\n* Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File\n\n* Other related duties as may be determined or assigned\n\n\n\n\nExperience\n\n\n* University degree required within a relevant discipline โ Life Sciences experience is a plus\n\n* Comprehensive understanding of DM related systems, technologies and standards\n\n* Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management\n\n* Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment\n\n* Highly organized and detail-oriented\n\n* Strong verbal and written communication skills with the ability to build relationships internally and with external partners\n\n* Highest levels of professionalism, confidence, personal values and ethical standards\n\n\n\n\n \n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n
$65,000 — $120,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nWaltham, Massachusetts, United States
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