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Clinical Data Lead - Alta Petens

Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 12, 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 a Clinical Lead - Alta Petens in our Cambridge office!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.OBJECTIVES/PURPOSE Takeda is advancing an exciting pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to ensure that we get our therapeutics to patients quickly by having the right operational model and integrated clinical data pipeline to support delivery.The Clinical Data Lead is responsible for leading the systems, process, and governance transformation for clinical trial data as part of a transformational data program. This data program will include an integrated data flow with end-to end control of data, internalization of numerous systems and processes, broad enablement of automation and near-time data access, efficient data review and query, and enablement of disruptive technologies for next-gen trial designs and insights. - The data program will encompass all systems, platforms and tools involved in the collection, processing, review, analysis, and downstream reporting or consumption of clinical trial data and will be inclusive of all Takeda therapeutic areas and relevant business units. You will report to our Head of Systems and Architecture.Delivery & Business Accountabilities -The Clinical Data Lead is expected to:

  • Lead the clinical data transformation to support Takeda R&D's vision to create a development engine and ecosystem that provides optimal clinical data control and quality in a predictable, automated & cost-effective way
  • Lead multi-faceted business process mapping to inform future-state clinical data flow and system and architecture design; Work with other leaders to ensure business impact is well-understood and accounted for within broader future fit development workstreams
  • Lead the selection and implementation of clinical data vendors, systems, platforms, and tools to support a transformed global data program
  • Define and embed appropriate quality oversight and governance tools and processes throughout data program in accordance with R&D policies
  • Oversee or manage key resources working on the operational data transformation team and/or operational data ecosystem
  • Oversee or manage key resources working on the clinical data transformation team and/or clinical data ecosystem
  • Engage and direct product owners and other supporting roles for all systems, data models and tools within clinical data ecosystem
  • In collaboration with other leaders, create and manage transition plans from former state to transformed state and lead or contribute to future-state processes
  • Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners
  • Provide strategic vision for long-term delivery innovationCORE ELEMENTS RELATED TO THIS ROLE Strategic Planning and Execution
    • Leads in setting clinical data goals, priorities, plans and schedules. Aligns and coordinates with corresponding workstreams and initiatives.
    • Visibly engages across the organization to ensure transformational impactFiscal Responsibility
      • Monitor and control expenditures; manages variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial objectives.Resource and Issue Management
        • Manages internal and external resources (people, information, technologies, time, and
        • Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to senior executive management and manages issues to resolution.Change Management
          • Supports strategies for effecting change, controlling change and helping people to adapt to change.Matrix Team Management
            • Provides matrix management, strategic and tactical leadership across data program.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
              • PhD with 8-12+ years experience, or MS with 12-15 years experience -in data management and/or database or statistical programming experience in pharmaceutical industry or health related field. -
              • Proven track record in identifying and implementing organization-wide initiatives, standards, and processes. -
              • In-depth knowledge of data management systems and processes, analysis and reporting principles. -
              • Strong understanding of the development and management of a standards library. -
              • Good knowledge of statistical programming languages (e.g. SAS) and statistical compute environments
              • 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. -
              • Knowledge of medical and statistical -terminology. -Comprehensive -understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc. -
              • Strong understanding -of system development lifecycle requirements -and -of US CFR, GCP and ICH
              • Experience working in Cloud Computing environments (ex AWS, Azure, etc)
              • Tolerance of ambiguity and willingness to work through complex issues -
              • Ability to work with global internal and external partners to achieve desired goals -
              • Ability to develop solutions to complex issues and challenges -
              • Promotes teamwork while working through solutions -#LI-KD1This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.EEO 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, Malden , Clinical Data Lead - Alta Petens, Healthcare , Malden, Massachusetts

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