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Senior Clinical Data Manager

5 days, 8 hours ago
Anywhere
Senior
Operations Specialist
Data Science and Analytics
GCP
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 2

Description

  • Oversee all clinical data management activities and deliverables across multiple clinical trials from study start-up through database lock and closeout.
  • Manage relationships with data management partners, including CROs and vendors.
  • Oversee outsourced study-related data management activities, including CRF design, data collection, edit checks, listings review, data reconciliation, medical coding, UAT testing, database lock, and archival of DM documents.
  • Ensure data quality and timely delivery of data management outputs in alignment with company goals.
  • Maintain data integrity and compliance with GCP, SOPs, and regulatory requirements, including Trial Master File documentation.
  • Represent data management in investigator meetings, CRA training, site visits, and company or department meetings.

Requirements

  • Bachelor’s degree in life sciences is required.
  • Minimum 5 years of clinical data management experience in a Sponsor and/or CRO setting.
  • Strong understanding of data management systems, technologies, standards, and data analytics platforms.
  • Comprehensive knowledge of drug development, clinical research processes, GCP guidelines, and clinical data management regulations.
  • Ability to work independently and collaboratively in a high-functioning team environment.
  • Detail-oriented with strong verbal and written communication skills.
  • Ability to build relationships internally and with external partners.
  • High levels of professionalism, confidence, personal values, and ethical standards.

Benefits

  • Remote work is available.
  • Opportunity to support clinical development programs in severe autoimmune diseases.

Interested in this position?

Apply directly on the company website

Apply Now

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