Senior Manager, Centralized Monitoring

🕒 April 8

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Flexible work arrangements