Dianthus Therapeutics, Inc.

Senior Clinical Data Manager

Dianthus Therapeutics, Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

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
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Applicant Tracking System Keywords

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Hard Skills & Tools
data managementdata aggregationdata analysismedical codingUAT testingdatabase lockdata reconciliationCRF designedit checkslistings reviews
Soft Skills
self-motivateddetail-orientedverbal communicationwritten communicationrelationship buildingcollaborativeprofessionalismconfidencepersonal valuesethical standards