Director, Clinical Data Standards

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OBJECTIVES/PURPOSE

• Responsible for driving the strategy for Takeda’s global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability.
• Actively participates in and influences Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Takeda's Therapeutic Area Clinical Data Standards Library.
• Supports enforcement of Takeda's Global Data Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.
• Actively leads the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally, and manages in-house programs along with standards vendor(s) to support Standards Management vision.
• Builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and has the ability to partner closely with internal/external standards stakeholders, and serves as a resource to support questions raised by regulatory agencies.

ACCOUNTABILITIES

• In collaboration with the Cross-functional SET and TAU Leaders, establishes and drives strategy of Takeda’s global data standards, processes, and technologies across the clinical data continuum ensuring quality of deliverables and global data interoperability.
• Develops the standards library (e.g., Veeva CDMS, Edit Checks, DTS, eCOA, IRT, CDISC, ADaM, TLFs) and ensures proper utilization of standards, adherence to all standards processes, and the timely, thorough assessment of library enhancements and deviations through Standards Governance.
• Builds relationships across the global Takeda organization and CRO partners in support of the standards vision and implementation.
• Has advanced knowledge of all standard library components and metadata across data collection, analysis, and reporting continuum and serves as a resource to support questions raised by regulatory agencies.
• Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
• Has strong working knowledge of clinical study processes and related regulatory requirements or information governance frameworks, (e.g., 21 CFR Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2], Good Clinical Data Management Practices, HIPAA, GDPR, etc.).
• Supervises staff and vendors developing standards library elements to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards.
• Oversees Standards Governance, manages deviations from standards content and processes, conducts periodic review and development of various metrics including assessment of standards utilization and development trends.
• Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, Phuse, Transcelerate, SCDM, EDC users group, SAS users group, etc.
• Actively communicates and ensures compliance with submission standards and guidance documents, regulatory agency expectations and industry trends as applicable to the Takeda organization. Actively participates and contributes at industry standards forums in support of Takeda’s assets.

CORE ELEMENTS RELATED TO THIS ROLE

• Leads a team to effectively govern and build standards library, align with leadership on operational strategy and engage stakeholders.
• Thorough knowledge and understanding of standards…