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Sr. Manager, Clinical Data Standards/ Standards Data Governance - Remote US

Company: Takeda Pharmaceutical
Location: Rochester
Posted on: November 24, 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 DescriptionTakeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases, and vaccines. Boston (Massachusetts) is the R&D headquarters.Clinical Data Sciences (CDS) at Takeda: Key to Takeda's success, the Clinical Data Sciences team provides strategic planning, integration, execution, build, and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review, and support downstream transformation and analysis.Clinical Data Sciences is comprised of the Clinical Data Engineering and Clinical Data Standards teams. The Clinical Data Standards team provides the standards for clinical data operation and ensures consistency to standards in Takeda's data flow, and the Clinical Data Engineering team drives the data architecture for clinical data. Clinical Data Standards also provide support to exploratory and specialty data for the purposes of data modeling, simulation, and analysis. - - - - - - - - - - - - - - - - - - - -Clinical Data Standards Governance Lead, Data Science Institute (DSI): Key to Takeda's success is the Clinical Data Standards team. The Clinical Data Standards Governance team provides strategic planning, integration, execution, build, and oversight of clinical data standards deliverables. Leads the governance of clinical data standards across all therapeutic areas along the clinical data value chain. The Clinical Data Standards team creates innovative ways to optimize standards deliverables to reduce timelines from protocol finalization to submission.Within Clinical Data Sciences, the Clinical Data Standards Governance manager will lead the governance team meetings and You will be a member of Takeda's dedicated and highly effective Clinical Data Standards team in Data Science organization. You will provide leadership in the planning and execution of Takeda's clinical Research supporting the clinical data standards process. You will ensure the efficient and collaborative conduct of Standards governance processes for Data Standards governance boards, and for monitoring the operational effectiveness of the committees and boards through regular monitoring and analysis of operational metrics. You will succeed by developing and maintaining collaborative partnerships with other functional and TAU heads.
As an advisor and an expert, you will be able to build and leverage constructive relationships across the organization to achieve Clinical Data Standards goals and objectives. You will be entrusted with driving data-driven excellence through our governance processes to benefit Takeda's portfolio of products and projects. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.Key Accountabilities:

  • Apply your extensive knowledge of standards and drug development and associated governance processes, leveraging precedents, and in collaboration with the Governance Leader and the Committee Chairs, you will monitor, develop and implement streamlined processes for effective and timely data standard development, review and approval.
  • Engage in a "continuous improvement", innovation-focused mindset in order to enhance the cross-functional governance and oversight process.
  • Provide project management leadership to Clinical Data Standards Boards (CDSB), working directly with the chairs and data standards team leads, facilitating meetings, offline reviews, and document review decisions. Create and maintain governance agendas, and track and coordinate review periods.
  • Identify opportunities, develop and deploy tools and approaches to correct and optimize areas of redundancy or weakness in existing or proposed processes for cross-governance and data standards review
  • Using your broad cross-functional experience, evaluate the content of review documentation and context of meeting/communications to ensure effective interactions; work with teams to resolve discrepancies/gaps/missing information to ensure successful interaction with data standards governance.
  • Develop and provide regular reports and recommendations to the Governance Leaders and functional leadership to assess governance body performance, make recommendations and implement corrective action as appropriate.
  • Working with Digital Data Technologies, create specifications for the design and maintenance of governance management tools for users to obtain information to enable efficient review and approval.
  • Lead and engage governance management and functional line efforts to champion, develop and apply the robust and efficient methodology to determine the impact of governance and oversight on the efficiency of protocol design as it relates to data standards evolution.
  • Routinely engage data standards governance and board members directly to solicit feedback to ensure effective operations. Incorporate observations as appropriate into operating principles.
  • Using experience and precedent, lead, collaborate and effectively influence limited duration workstreams which are working to enhance data-related processes.
  • Challenge the status quo, promote innovation, and take appropriate risks to drive improved outcomes.
  • Bring your knowledge of current clinical data standards and sufficient expertise to contribute to and influence discussions pertaining to standards.
  • In conjunction with the chairs of the CDSBs, coordinate and lead global, cross-functional meetings/teleconferences (e.g. defining requirements) to ensure adequate business and technical review of complex issues raised regarding potential modification to the clinical data standards.
  • Baseline current process, develop metrics needed to assess the ability of the clinical data standards governance bodies to manage and mitigate change effectively; adopts an innovative, "continuous improvement" approach to both process and outcomes.
  • Provide clear and timely feedback and communications with study teams and other customers who have open requests and assist them in advancing to resolution as efficiently as practical to avoid any delays to study timeline ---Additional Activities
    • Assists with quality review of the above activities performed by any external vendor, as needed. -
    • Adhere to SOPs for computer system validation and all health authority, ICH (International Council for Harmonization) GCP (Good Clinical Practice) regulations.
    • Ensure compliance with own Learning Curricula, corporate, and/or GxP requirements. -
    • Performs other duties as assigned within timelines. -Educational Qualification:
      • Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology, or other health-related field or equivalent experience that provides the skills and knowledge necessary to perform the job.Experience:
        • Minimum of 5 years experience in clinical data collection instruments or similar applications in a programming or administration capacity. Minimum of 1-year experience with Medidata Rave and/or Rave certification.
        • Knowledge of at least one clinical data management system and/or working knowledge of programming language.
        • Must understand database concepts. Knowledge of XML, ALS, and MDR preferred.
        • Strong working knowledge of clinical trial terminology and Architect Loader Specification expected.
        • Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively.
        • Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Strong knowledge of MS Word, Excel, PowerPoint, Access, and Outlook.
        • Ability to work independently, take initiative, and complete tasks to deadlines.Special Skills/Abilities:
          • Strong attention to detail, and organizational skills -
          • Good time management skills -
          • Quick learner and comfortable learning new technologies and systems -
          • Good knowledge of office software (Microsoft Office). -Behavioral Competencies:
            • Is comfortable with ambiguity. -
            • Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills. -Job Complexity:
              • Low-Medium complexity project. -
              • Occasional domestic/international travel to other Takeda sites, strategic partners, and therapeutic area events may be required. -Supervision: -
                • Supervision required, should be able to function collaboratively (with guidance) with all levels of employees. -License/Certifications: -
                  • Preferred to have CDISC accreditations. -Physical Demands: -
                    • Ability to sit and stand for long periods of time. -
                    • Carrying, handling, and reaching for objects.
                    • Manual dexterity to operate office equipment i.e. computers, phones, etc.Travel Requirements: -
                      • Requires approximately 1-2 domestic trips annually and up to 1 international trip. -In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.Base Salary Range: $130,200.00 - $186,000.00, based on candidate professional experience level. - Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.This position is currently classified as "Remote" in accordance with Takeda's Hybrid and Remote Work policy.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

Keywords: Takeda Pharmaceutical, Rochester , Sr. Manager, Clinical Data Standards/ Standards Data Governance - Remote US, Healthcare , Rochester, New York

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