Senior Associate, Clinical Data Standards Management (CDSM)

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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:

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Support development and maintenance of global clinical data standards and operational data mappings

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Apply CDISC standards (CDASH, SDTM controlled terminology) in standards development

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Develop and maintain global library objects (eCRFs, edit checks, dynamics etc.)

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Assist in regular releases of the Global Library Volume (GLV)

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Contribute to CRF Completion Guidelines development

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Work within multiple technologies to promote the development, maintenance and releases of the GLV (Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, Veeva Vault, etc.)

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Support consistency and adherence to Kite standards across programs and portfolios

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Support Standards Core Committee (SCC) and Standards Governance Committee (SGC) activities including preparation of materials, documentation of decisions and follow-up of action items

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Partner with functional stakeholders to support standards adoption

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Identify and suggest process improvements and support standards-related initiatives

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Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines and internal procedures

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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.

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Execute assigned global library build and maintenance activities

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Perform quality checks to ensure standards implementation aligns with defined specifications

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Document all standards release activities appropriately

Basic Requirements

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Doctorate and Clinical Data Standards or EDC Programming experience

- OR

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Master’s and 3+ years of Clinical Data Standards or EDC Programming experience

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Bachelor’s and 5+ years of Clinical Data Standards or EDC Programming experience

Preferred Qualifications

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Strong desire and passion to work in Clinical Data Standards development with demonstrated interest in process improvement and operational excellence

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Working knowledge of CDISC standards (CDASH, SDTM, ADaM)

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Experience programming in Medidata Rave EDC

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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 Integr