Posted to MedZilla HealthCare on 12/12/2018


Takeda Pharmaceuticals

US-MA, Director, Clinical Data Standards R0003439-MZ


 
 

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Job Description

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 working on the Clinical Data Technology team, you will be empowered to collaborate with Takeda leaders and oversee Takeda standards, processes and procedures, and a typical day will include:

POSITION OBJECTIVES:

  • 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.

POSITION ACCOUNTABILITIES:

  • 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, EXPERIENCE 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

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-PW1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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