Senior Associate, Clinical Data Standards Management (CDSM)

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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