Dianthus Therapeutics - Senior Manager/Associate Director, Centralized Monitoring

Remote - USA *2mo ago

Remote Senior NA Clinical Research Cloud Computing Associate Senior Community Manager Reporting GCP CRO Process Optimization Data Quality

Requirements

• Minimum of 5 years of experience in clinical research, including experience as a Sr. Clinical Research Associate (CRA), Lead CRA, or in a data oversight role. Registered Nurse (RN), or equivalent clinical/medical background (e.g., MD, PA, study coordinator) preferred. • Strong understanding of clinical trial processes, GCP, and global regulatory requirements. • Experience working with CROs and managing outsourced data review activities. • Proficiency in reviewing EDC systems and clinical data listings. [Experience with targeted source data verification (tSDV) strongly preferred.] • Excellent analytical, critical thinking, organizational, and communication skills. • Experience with process improvement initiatives (e.g., process revision, plan development, SOP development, etc.) • Ability to work independently in a fast-paced, startup environment.

Responsibilities

• Lead and manage clinical data review activities across assigned studies. • Actively participate in data review and protocol deviation review meetings. • Collaborate with CROs to oversee data cleaning, query resolution, and database lock processes. • Review clinical data, data listings, and reports to identify inconsistencies, trends, and potential issues. • Identify, assess, and escalate data anomalies and protocol deviations. • Partner with Clinical Development Operations, Clinical Development, Data Management, and Biostatistics to ensure data quality and compliance. • Develop and implement data review plans and contribute to data management plans. • Support Data Management activities (e.g., CRF design, User Acceptance Testing) • Participate in CRO oversight, including performance monitoring and issue resolution. • Support audit readiness and regulatory inspections by ensuring data traceability and documentation. • Mentor junior team members and contribute to process improvement initiatives.