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Job DescriptionThe Senior Associate, Clinical Data Standards Management (CDSM) supports the development, implementation, and maintenance of global clinical data standards across clinical programs. This role collaborates with Data Management, Clinical Programming, Biostatistics, and Clinical Operations to ensure consistent, high-quality, and regulatory-compliant standards implementation. The position is a hands-on contributor focused on global library development, governance support, and study-level integration. The Senior Associate, Clinical Data Standards Management reports to the Director of Clinical Data Management (CDSM) and works under the guidance of the Manager, Senior Manager and Associate Director to execute clinical data standards activities.
Responsibilities include, but are not limited to: - Support development and maintenance of global clinical data standards and operational data mappings
- Apply CDISC standards (CDASH, SDTM controlled terminology) in standards development
- Develop and maintain global library objects (eCRFs, edit checks, dynamics etc.)
- Assist in regular releases of the Global Library Volume (GLV)
- Contribute to CRF Completion Guidelines development
- Work within multiple technologies to promote the development, maintenance and releases of the GLV (Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, Veeva Vault, etc.)
- Support consistency and adherence to Kite standards across programs and portfolios
- Support Standards Core Committee (SCC) and Standards Governance Committee (SGC) activities including preparation of materials, documentation of decisions and follow-up of action items
- Partner with functional stakeholders to support standards adoption
- Identify and suggest process improvements and support standards-related initiatives
- Ensure compliance with regulatory requirements, industry standards, Google Cloud Platform/ICH guidelines and internal procedures
- Provide study support during the initial EDC build on new studies including implementation of standards and facilitating Change Management, issue resolution, impact analysis, proposing solutions and escalation where appropriate.
- Execute assigned global library build and maintenance activities
- Perform quality checks to ensure standards implementation aligns with defined specifications
- Document all standards release activities appropriately
Basic Requirements - Doctorate and Clinical Data Standards or EDC Programming experience
- OR
- Master's and 3+ years of Clinical Data Standards or EDC Programming experience
- OR
- Bachelor's and 5+ years of Clinical Data Standards or EDC Programming experience
Preferred Qualifications - Strong desire and passion to work in Clinical Data Standards development with demonstrated interest in process improvement and operational excellence
- Working knowledge of CDISC standards (CDASH, SDTM, ADaM)
- Experience programming in Medidata Rave EDC
- Experience with at least some Medidata Rave modules including Rave Coder, Targeted SDV (TSDV), ePRO, Lab Admin, Rave Safety Gateway (RSG), Core Configuration and IRT Integrations
- Experience in global library development
- Understanding of clinical trial data collection and CRF design
- Understanding of clinical data management processes including query management, site concerns, and data collection standards
- Familiarity with FDA, EMA, ICH, and Google Cloud Platform requirements
- Strong communication and cross-functional collaboration skills
- Detail-oriented with ability to ensure consistency across studies
- Working knowledge of regulatory requirements and industry guidance, including FDA, EMA, ICH and Google Cloud Platform
The salary range for this position is: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit Sign up to follow @KitePharma on Twitter at ;br>
For jobs in the United States:Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.
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