Director, Clinical Data Standards

Takeda

19h • Remote

About The Position

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 development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations. Proven track record in development and management of standards library and in-depth knowledge of study design through submission

Requirements

• BS/BA or MS in a life science or analytical area with over 12 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
• Minimum 12 years of clinical data management and/or database or statistical programming experience in pharmaceutical industry or health related field.
• Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations.
• Proven track record for development and management of standards library in addition to in-depth knowledge of study design implementation, to define standards eCRFs, edit checks, best practices in EDC and other data acquisition sources.
• knowledge of statistical programming languages (e.g., SAS, R, Python, etc.).
• Expertise in the requirements and technology required to support electronic data capture and electronic submissions.
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
• Proven track record in managing global, cross-functional standards and processes, support a culture of continual improvement and innovation; promotes knowledge sharing.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
• Pragmatic and willing to drive and support change and comfortable with ambiguity.
• Direct experience in the pharmaceutical industry or related field required.
• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering programs with complex business deliverables.
• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams.
• Strong judge of talent with the ability to make tough talent decisions.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Nice To Haves

• Desirable CDM technical expertise (e.g., EDC Veeva and/or Rave, elluminate).

Responsibilities

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

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director