Clinical Data Management Consultant

Summary

Join Kyverna Therapeutics, a clinical-stage biopharmaceutical company, as a Clinical Data Management (CDM) Consultant. You will oversee all aspects of clinical data management for Kyverna’s clinical trials, ensuring high-quality data and regulatory compliance. This role involves managing CROs, developing SOPs, supporting BLA filings, and utilizing Medidata Rave EDC. The ideal candidate possesses extensive experience in clinical data management within the biotech/pharmaceutical industry and expertise in clinical trial data monitoring and regulatory submissions. The position is remote. Kyverna values intellectual humility, collaboration, and a commitment to improving autoimmune disease treatments.

Requirements

• Bachelor’s degree in life sciences, computer science, or a related field
• 10+ years of experience in clinical data management, preferably within the biotech or pharmaceutical industry
• Expert knowledge of clinical trial data monitoring, CRO oversight, and clinical data standards
• Hands-on experience with Medidata Rave EDC and clinical database design
• Strong experience with UAT for clinical trial systems
• Proficiency in CRF development, data validation, and query management
• Demonstrated success in supporting regulatory submissions (BLA, NDA, etc.)
• Strong knowledge of GCP, FDA, and ICH guidelines
• Excellent analytical, problem-solving, and project management skills
• Ability to work in a fast-paced, growing environment and lead initiatives independently

Responsibilities

• Oversee CROs and external vendors to ensure data quality, integrity, and adherence to study timelines
• Develop and maintain data management plans, standard operating procedures (SOPs), and work instructions to ensure compliance with regulatory requirements
• Support regulatory submissions, including BLA filings, by providing high-quality, audit-ready clinical data
• Ensure effective clinical trial monitoring and data review processes are in place
• Conduct and oversee user acceptance testing (UAT) for electronic data capture (EDC) systems
• Manage case report form (CRF) design, development, and implementation
• Provide subject matter expertise in Medidata Rave EDC, ensuring optimal setup and functionality

Preferred Qualifications

• Experience in cell therapy, immunotherapy, or autoimmune disease clinical trials
• Prior experience establishing and growing an in-house clinical data management function
• Strong communication and leadership skills, with the ability to influence and collaborate cross-functionally