Dianthus Therapeutics, Inc.
Unlocking the full potential of complement therapeutics through the power of selectivity.
Senior Clinical Data Manager
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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