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Head of Clinical Data Management

Company: Takeda Pharmaceutical
Location: West Orange
Posted on: May 11, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Vice President, Head of Clinical Data Management.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver -Better Health and a Brighter Future -to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.Responsible for:

  • Establish and drive global data management strategy related to resourcing, technologies and processes to maximize efficiency, innovation and data quality
  • Lead and organize the global data management function to provide data collection, management and integration expertise in support of global development projects and marketed products including all therapeutic areas and business units; ensure functional strategy supports the portfolio priorities
  • Accountable for meeting annual goals, objectives and deliverables for both internal and external Clinical Data Management (CDM) stakeholders
    • Develops, implements and oversees an operational data ownership strategy in support of the global portfolio
    • Liaise with various internal and external groups (GPTs, regions, Clinical Operations, Statistical and Quantitative Sciences, Global Patient Safety Evaluation, and external vendors and CROs) for the implementation of data management activities needed for clinical studies across all phases of clinical drug development.
    • Provide insight on latest technologies and changes in regulatory environments, enabling emerging priorities and efficient data management leadership for global development programs.
    • Lead systematic professional development and provide strong support for direct reports and other members of the Clinical Data Management functionACCOUNTABILITIES
      • Data management and data integrity oversight:
      • Ensure timely and high-quality data management deliverables supporting the Takeda portfolio
      • Responsible for Sponsor Oversight of Data Management deliverables and activities performed by Strategic Partners, CROs, other 3rd Party Vendors or FSPs
      • Responsible for the receipt and management vendor data to ensure asset and study level strategies are properly - implemented
      • Lead implementation of clinical data management best practices (e.g., cross-functional data review, emerging data collection technologies, etc.)
      • Data Operations and FSP Management
      • Accountable for resourcing algorithms,
      • Serve as Subject Matter Expert and data-specific liaison for Process, Training and Compliance and other internal initiatives/projects
      • Design and implement clinical data management best practices, ensuring engagement with key stakeholders on critical processes such as cross-functional data review; issue escalation, etc.
      • Build and maintain relationship with one or more Functional Service Providers, designed to provide staff augmentation and support build of new and/or improved data management capabilities
      • Metrics, Analytics and Reporting
      • Lead development of Clinical Data Management metrics, represent CDM function in projects and initiatives related to the reporting and analytics capabilities, including but not limited to R&D Dashboards, Portfolio level performance and productivity and predictive analytics/reporting
      • Business ownership of systems and definitions and ongoing support of clinical dataEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
        • BS degree in Computer Science, Life Science or other technical field required; advanced degree desired.
        • 15-20+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
        • 10-15+ years of data management and leadership experience
        • Knowledge of clinical data management principles, regulations and best practices, as well as common software products and technologies used in drug development
        • Ability to develop and evaluate business cases and effectively manage budgets
        • Good knowledge of FDA and ICH regulations and industry standards applicable to drug development systems
        • Knowledge of regulations and best practices related to data collection, electronic records and signatures and data privacy.
        • Senior leadership experience in Clinical Data Management or related field, leading a medium to large organization and influencing executive-level management and key stakeholders
        • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
        • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
        • 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 industryThis position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy
          • 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 ProgramsIn accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.Discover more at -takedajobs.comNo Phone Calls or Recruiters Please.ADDITIONAL INFORMATIONTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.#LI-CS1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, West Orange , Head of Clinical Data Management, Executive , West Orange, New Jersey

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