US-MA, Director, Clinical Data Standards R0012303-MZ
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Clinical Data Standards in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director, Clinical Data Standards working on the Clinical Operations team, you will be empowered lead cross-functional standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization and a typical day will include:
In collaboration with the Clinical Data Solutions Leadership Team, and TAU Leaders, establishes and drives strategy of Takeda s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability.
Responsible for establishing and managing a Standards vendor to support Standards Management vision.
Responsible for Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.
Builds relationships across the global Takeda organization and with CRO partners in support of the standards vision and implementation.
Participates with and influences at industry standards forums in support of Takeda s therapeutic areas.
Serves as a resource to support questions raised by regulatory agencies.
Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum
Works with Clinical Data Solutions Leadership Team, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy
Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization
Provides strategic guidance toward execution of a comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives
Supervises staff and vendors developing standards library to ensure alignment to standards strategy
Develops training strategy and ensures consistent training program for standards
Provides senior oversight to vendor/CROs for utilization of Takeda standards
Conducts periodic review and development of metrics to assess standards utilization and development trends
Oversees Standards Governance, managing deviations from standards content and processes
Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, etc
Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization
Complies with all applicable regulatory requirements and Takeda standards and procedures
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA or MS in a life science or analytical area
12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field.
8+ years experience supporting clinical trials across all phases of development.
5+ years of progressive management experience.
Proven track record for development and management of a standards library.
In-depth knowledge of data management systems and processes, analysis and reporting principles.
Good knowledge of statistical programming languages (e.g. SAS). Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS.
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. Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.
Able to influence without authority Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
Pragmatic and willing to drive and support change
Is comfortable with ambiguity
Support a culture of continual improvement and innovation; promote knowledge sharing
Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.
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