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Project Lead, Clinical Data - Alta Petens

Company: Takeda Pharmaceutical
Location: Bronx
Posted on: June 22, 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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionOBJECTIVES/PURPOSE:Takeda is advancing an exciting product pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to get our therapeutics to patients safely and quickly via an optimized operational model and integrated clinical data pipeline.The Clinical Data Project Lead is responsible for leading projects related to the clinical data pipelines, systems, processes, and governance part of a transformational clinical data program. The clinical 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. Multiple Project Leads will be hired to lead and collaborate on projects. Projects will include Protocol Digitization; Electronic Data Capture Systems; Data Integration, Review and Query Platforms; Data Visualizations; Complex Data Pipelines and other technology projects related to end-to-end clinical data flow.DELIVERY & BUSINESS ACCOUNTABILITY:The Clinical Data Project Lead is expected to:

  • Lead specific projects in 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
  • Help 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
  • Help define and embed appropriate quality oversight and governance tools and processes throughout data program in accordance with R&D policies
  • Engage with stakeholders for all systems, data models and tools within clinical data ecosystem
  • Help facilitate the transition plans from former state to transformed state and contribute to future-state processes
  • Serve as a leader within Takeda and outside of Takeda with vendors and partners
  • Help shape the strategic vision for long-term delivery innovation
  • Communicate challenges and successes within project groups
  • Leverage strong leadership and interpersonal skills in managing delivery/analyst teams.CORE ELEMENTS RELATED TO THIS ROLE:Strategic Planning and Execution:
    • Helps develop and reach clinical data goals, priorities, plans and schedules.
    • Engages with leadership and analysis teams to ensure transformational impactFiscal Responsibility:
      • Manages and reports expenditures, being cognizant of variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial objectives.Resource and Issue Management:
        • Helps manage internal and external resources (people, information, technologies, time, and capital) within the clinical data team
        • Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to Clinical Data Lead to resolution.Change Management:
          • Supports strategies for effecting change, controlling change, and helping people to adapt to change.Matrix Team Management:
            • Provides strategic and tactical leadership across the clinical data projects
            • Work closely with the management team to execute the work and maintain intercollaborative communication with external teams, as neededDIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise:
              • Background in clinical trial execution and clinical data systems, processes and reportingLeadership:
                • Inspires, motivates and drives results
                • Communicates clearly, persuasively conveying both ideas and data, verbally and in writingDecision-making and Autonomy:
                  • Provides input to highly complex decisions that impact overall clinical data management and R&D
                  • Seeks diverse input from multiple constituents and stakeholders to drive innovative solutions
                  • Incorporates feedback and ensure decisions are implemented swiftly to yield flawless executionInteraction:
                    • Effectively represents program in negotiations with the ability to resolve conflict in a constructive manner
                    • Builds strong relationships and collaborate effectively with other interfacing Takeda functionsInnovation:
                      • Recommends, influences and implements organizational change and continuous innovation
                      • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
                      • Serves as a role model, demonstrating respect and inclusion, creating a culture that fosters innovationComplexity:
                        • Works in a global ecosystem (internal and external) with a high degree of complexity
                        • Recognizes broad, enterprise level perspective
                        • To succeed, the role requires deep understanding of clinical development processes and exceptional attention to detail.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                          • Advanced degree with 7+ years experience in data-related field and experience in pharmaceutical industry or health related field
                          • Experience in pharmaceutical industry or health related field.
                          • Experience with identifying and implementing organization-wide initiatives, standards, and processes.
                          • Knowledge of data management systems and processes, analysis and reporting principles.
                          • Knowledge of programming languages (e.g. SAS, R, Python) and analytics environments
                          • 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.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, New Rochelle , Project Lead, Clinical Data - Alta Petens, Healthcare , Bronx, New York

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