Senior Manager, Clinical Data Management (CDM)

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated

Kyverna is recruiting a Senior Manager, Clinical Data Management (CDM) in its Quantitative Sciences organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why. 

The Senior Manager, Clinical Data Management (CDM) will be responsible for overseeing all aspects of clinical data management activities for Kyverna’s clinical trials. This individual will play a key role in ensuring high-quality data collection, analysis, and reporting while maintaining compliance with regulatory requirements. The successful candidate will provide oversight of CROs, develop and implement SOPs, and support BLA filings. 

• Lead and manage clinical data management activities across all Kyverna-sponsored clinical trials. 
• 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. 
• Partner with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory to ensure data management deliverables align with project goals. 
• Proactively identify and mitigate risks related to clinical data management. 

• Bachelor’s degree in life sciences, computer science, or a related field. 
• 8 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. 
• 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. 

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets