Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Sr Manager, Clinical Data Management
Reporting to: VP, Biometrics
Location: Remote - Must work west coast hours
Summary
The Sr. Manager, Clinical Data Management is responsible for leading clinical data management activities across multiple studies, from study start-up through database lock and regulatory submission. This role provides operational leadership to ensure the delivery of high-quality, inspection-ready clinical data in compliance with global regulatory requirements. By working closely with biostatistics, statistical programming, clinical operations, and other cross-functional stakeholders, as well as external CROs, the position will ensure delivery of accurate, timely, consistent, and high‐quality clinical data to support business needs.
ResponsibilitiesSupport the design, specifications, and development of eCRFsSupport the design and testing of technical CDM components including edit checks, reports, and listingsDevelop Data Management Plan documents Perform comprehensive review of data generated from the clinical study including third party/external data, SAE data and local lab data, as applicableManage effective communication of data issues and discrepancies to study sites via the query management processProvide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification / mitigation activitiesEnsure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Kyverna SOPs, regulatory guidelines, and study specific plans. Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycleCommunicates effectively across functions to ensure that all issues are resolved according to guidelines and requirements. Escalates relevant issues to clinical study management team to facilitate timely resolution. Investigates and analyzes possible solutions QualificationsBachelor’s degree in life sciences, health informatics, or related field8+ years of Clinical Data Management experience in a CRO / Pharma settingProficiency with clinical data systems (e.g., Medidata Rave, Oracle Clinical), and use of Data Review tools Proficient in data cleaning and query resolution techniquesHigh attention to detail including proven ability to manage multiple, competing priorities, and ability to work under pressure Excellent written and oral communication skillsIn depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operationsUnderstanding of CDISC standards, clinical trial design, and regulatory requirementsOperational expertise in the strategic planning and delivery of CDM deliverables at study and / or program level. Experience in management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned studies and programsThe salary range for this position is $160,000 to $175,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
#LI_DNI
