Operational Project Lead, Structured Content Management

Company: Takeda Pharmaceutical
Location: Framingham
Posted on: August 6, 2022

Job Description:

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Job Description

OBJECTIVES/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.

T he Project Lead is responsible for leading the development and implementation of structured content management (SCM) capability as part of a transformational clinical data program inclusive of all clinical trial patient and operational data. This SCM capability applied to multiple use cases will be a critical component of Takeda s integrated clinical data flow that will entail end-to-end control of data, internalization of numerous systems and processes, broad enablement of automation and near-time data access, efficient and automated data quality checks, and enablement of disruptive technologies for next-gen trial op erations 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 t rial operations data and will be inclusive of all Takeda therapeutic areas and relevant business units.

DELIVERY & BUSINESS ACCOUNTABILITIES

The Project Lead, Structured Content Management is expected to:

• Lead the structured content management capability development, implementation, and expansion to support Takeda s clinical data pipeline
• Help lead multi-faceted business process mapping to inform future-state trial operations data flow and system and architecture design; Work with other leaders to ensure the business impact is well-understood and accounted for within broader future-fit development workstreams
• Support the selection and implementation of 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 the data program in accordance with R&D policies
• Engage with stakeholders for all systems, data models, and tools within the operational data ecosystem
• Help facilitate the transition plans from the former state to the 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 analyst teams.
  CORE ELEMENTS RELATED TO THIS ROLE
  
  Strategic Planning and Execution
  • Helps develop and reach trial operations data goals, priorities, plans, and schedules.
  • Engages with leadership and analysis teams to ensure transformational impact
    Fiscal 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 operational data team
        • Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to Trial Operations Data Lead
          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 trial management systems/operational data projects
              DIMENSIONS AND ASPECTS
              
              Technical/Functional (Line) Expertise
              • Executes R&D leadership with a background in clinical trial execution and operational data systems, processes, and reporting
                Leadership
                • Inspires, motivates, and drives results
                • Communicates clearly, persuasively conveying both ideas and data, verbally and in writing
                  Decision-making and Autonomy
                  • Provides input to highly complex decisions that impact overall trial operational data management and R&D
                  • Seeks diverse input from multiple constituents and stakeholders to drive innovative solutions
                  • Incorporates feedback and ensures decisions are implemented swiftly to yield flawless execution
                    Interaction
                    • Effectively represents the program in negotiations with the ability to resolve conflict in a constructive manner
                    • Builds strong relationships and collaborates effectively with other interfacing Takeda functions
                      Innovation
                      • 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 innovation
                        Complexity
                        • Works in a global ecosystem (internal and external) with a high degree of complexity
                        • Recognizes broad, enterprise-level perspective
                          EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                          • Advanced degree with 1 0 + years experience in data-related field and experience in the pharmaceutical industry or health-related field
                          • Experience with identifying and implementing organization-wide initiatives, standards, and processes
                          • Experience within clinical trial execution and clinical trial lifecycle
                          • Strong experience in process development management, content management, inspection readiness, and experience with clinical trial systems such as TMF and CTMS; Experience with Veeva Vault Clinical Platforms desired
                          • Solid understanding of system development lifecycle requirements and of US CFR, GCP, and ICH
                          • Experience working in Cloud Computing environments (ex AWS, Azure, etc.)
                          • Strong leadership skills with a wide range of global R&D stakeholders
                          • 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
                            This position is currently classified as "hybrid" in accordance with Takeda s Hybrid and Remote Work policy.
                            
                            Takeda 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 .
                            
                            EEO Statement
                            
                            Takeda 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.
                            
                            Locations
                            
                            Boston, MA
                            
                            Worker Type
                            
                            Employee
                            
                            Worker Sub-Type
                            
                            Regular
                            
                            Time Type
                            
                            Full time

Keywords: Takeda Pharmaceutical, Framingham , Operational Project Lead, Structured Content Management, Executive , Framingham, Massachusetts