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Senior Associate, Clinical Data… at Gilead Sciences · United…
Job Description
Senior Associate, Clinical Data Standards Management (CDSM)
Location: United States – Remote · Remote
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
The 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, GCP/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 GCP 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 GCP
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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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 ApplicantAccommodations@gilead.com for assistance.
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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.
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For Current Kite Pharma Employees and Contractors:
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