Associate Director, Clinical Data Standards

Company: Takeda Pharmaceutical
Location: Cresskill
Posted on: May 9, 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 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.Statistical & Quantitative Sciences (SQS) at TakedaKey to Takeda's success is the Statistical & Quantitative Sciences Team (SQS), providing Strategic planning, resourcing, and oversight of clinical trial data deliverables.SQS engages in strategic partnerships, overseeing expert CROs to ensure successful execution and delivery of Clinical Data. SQS also owns Takeda's strategy for the development and governance of Data Standards, in alignment with the CDISC (Clinical Data Interchange Standards Consortium) industry standards. SQS performs oversight and in-house activities pertaining to standards and study data. SQS is responsible for Data Collection (e.g., EDC, IVR, ePRO, eCOA), Data Tabulation, Data Analysis and Reporting technologies and other related tools and/or applications.Associate Director, Clinical Data StandardsThe Associate Director, Clinical Data Standards is responsible for driving the strategy for Takeda's global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. They are Takeda's Data Standards Leaders and SMEs, actively participating in and influencing Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Takeda's Therapeutic Area Clinical Data Standards Library. -The Associate Director, Clinical Data Standards supports enforcement of Takeda's Global Data Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations. They are leading the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally, manages in-house programs along with standards vendor(s) to support Standards Management vision.The Associate Director, Clinical Data Standards builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and have the ability to partner closely with internal/external standards stakeholders, and serves as a resource to support questions raised by regulatory agencies.Key Accountabilities:

• Provides input to functional governance with Takeda's strategic suppliers. - Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
• Participates and represents function in formal inspections and audits as requested.
• Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function's KPIs.
• Represents function in external professional initiatives and organizations such as CDISC, pHUSE, SCDM, SCOPE, PharmaSug, TransCelerate, Accumulus, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
• Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables. -
• Contributes to the development of strategies and governance for assessing, implementing, and integrating systems and tools to support, manage, govern and report on data standards
• Responsible for the maintenance of structure and content of Takeda's MDR - Metadata Repository in one or more of the areas: data transfer specifications, eCRF and other data collection methods e.g., eSource, ePRO, forms, controlled terminologies, instructions, edit checks, SDTM mappings, ADaM and TFL standard libraries.
• Leads and enforces maintenance and decommissioning of Clinical Data Standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires) through the use of metadata repository. Includes regular assessment of standards content with respect to compliance and industry impacts.
• Performs other duties as assigned.Educational Qualifications:
  • BS/BA required preferably in a health-related, life science area or technology-related fields.Experience:
    • Successful experience managing vendor relationships and alliance partnerships with at least 4 years' experience in this area.
    • Minimum 3 years of line management experience or equivalent.
    • Experience with all phases of development in one or more therapeutic areas preferred.
    • Ability to handle multiple development programs simultaneously.
    • NDA/CTD Experience preferred.
    • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
    • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
    • Minimum of 10 years developing and managing clinical data standards, or drug development process with expertise in the cross-functional interfaces with Biometrics functions (e.g., Data Management, EDC build, Statistical Programming & Biostatistics)Behavioral Competencies:
      • Pragmatic and willing to drive and support change.
      • Is comfortable with ambiguity.
      • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
      • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
      • Demonstrated strong matrix leadership and communication skills.Job Complexity:
        • High complexity at program that include multiple projects and/or platforms.
        • Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.Supervision:
          • Minimal supervision required, should be able to function independently and collaboratively with all levels of employees.Base Salary Range: $ 137,200 to $ 196,000, 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 posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.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

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