Sr. Manager, Clinical Data Management jobs in United States
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Kyverna Therapeutics · 19 hours ago

Sr. Manager, Clinical Data Management

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Sr. Manager, Clinical Data Management is responsible for leading clinical data management activities across multiple studies, ensuring the delivery of high-quality clinical data in compliance with global regulatory requirements. This role involves collaboration with various stakeholders to support business needs and maintain an inspection-ready environment throughout the study lifecycle.

BiotechnologyLife ScienceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Support the design, specifications, and development of eCRFs
Support the design and testing of technical CDM components including edit checks, reports, and listings
Develop 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 applicable
Manage effective communication of data issues and discrepancies to study sites via the query management process
Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification / mitigation activities
Ensure 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 lifecycle
Communicates 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

Qualification

Clinical Data ManagementClinical data systemsData cleaning techniquesCDISC standardsClinical trial processVendor managementCommunication skillsAttention to detail

Required

Bachelor's degree in life sciences, health informatics, or related field
8+ years of Clinical Data Management experience in a CRO / Pharma setting
Proficiency with clinical data systems (e.g., Medidata Rave, Oracle Clinical), and use of Data Review tools
Proficient in data cleaning and query resolution techniques
High attention to detail including proven ability to manage multiple, competing priorities, and ability to work under pressure
Excellent written and oral communication skills
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
Understanding of CDISC standards, clinical trial design, and regulatory requirements
Operational 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 programs

Benefits

Bonus
Benefits
Participation in Company’s stock option plan

Company

Kyverna Therapeutics

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Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.

H1B Sponsorship

Kyverna Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2021 (1)

Funding

Current Stage
Public Company
Total Funding
$295M
Key Investors
Oxford Finance LLCNorthpond Ventures
2025-12-17Post Ipo Equity· $100M
2025-11-03Post Ipo Debt· $25M
2024-02-08IPO

Leadership Team

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Marc Grasso
Chief Financial Officer
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Tom Van Blarcom
Senior Vice President, Head of Research
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Company data provided by crunchbase