Sr. Manager, Clinical Data Standards/ Operations & Study Support - Remote US

Company: Takeda Pharmaceutical
Location: Hamilton
Posted on: November 19, 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 supporting 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 Operations and Study support 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 Operations and study team leads all activities to support clinical study operations. 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:

• Support study requests, follow standards processes for study request triage and progression to completion within customer requested time frame
• Collaboration within the standards team and also wider with study teams and cross-functionally and therapeutically
• Support individual requests and follow Standards SOPs to build Global and TA level standards
• Leads or contributes to the development and maintenance of Clinical Data Standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, TFLs and questionnaires). - Includes periodic assessment of standards content with respect to compliance and industry impacts.
• Leads the development and maintenance of project plans and effectively articulates them; defines risks and recommends contingency plans
• Leads standards compliance review and works with functional areas and CROs/strategic service providers to reinforce content and interpretation of Takeda standards
• Acts as Standards area project manager or team leader for selected standards projects and teams.
• Develops strategy for Standards Management technology selection and deployment across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models.
• Performs other duties as assigned.Additional Activities:
  • Assists with quality review of the above activities performed by an 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 Rave Study Builder Certification. -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, etcTravel Requirements: -
                    • Requires approximately 1-2 domestic trips annually and up to 1 international trip. -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

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