Dianthus Therapeutics, Inc.

Unlocking the full potential of complement therapeutics through the power of selectivity.

Senior Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteTeam 1-10Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

46 days ago

Salary

Not specified

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

• Play a critical role within the team leading data management processes for clinical trials. • Oversee all clinical data management and related deliverables from start-up through close out. • Independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data. • Support data aggregation and analysis in the advancement of patient care. • 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, 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.

Job Requirements

  • 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.

Benefits

  • We are open to you working remotely.

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