Senior Manager, Clinical Data Standards

Company: Takeda Pharmaceutical
Location: Levittown
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 DescriptionREMOTE JOB OPPORTUNITY!Job Title:Senior Manager, Clinical Data StandardsReports to:Director, Head, Clinical Data StandardsTakedaTakeda 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 guided by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop 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 main focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.Senior Manager, Clinical Data StandardsA the Senior Manager Clinical Data Standards, you will oversee the development, deployment, management and governance of clinical standards. They are Takeda's Data Standards Leaders and SMEs, actively engaged in Data Standards forums (internally or externally) to maintain awareness of any plans and trends that could be incorporated into, or enhance Takeda's Clinical Data Standards Library.You will lead the identification, review/evaluation, deployment and usage of technologies to distribute and integrate with and report on standards compliance internally and collaboratively with CROs/strategic service providers.Key Accountabilities

• Represent Takeda and Global Development Operations as a member of Standards Development Organization or Standard Support Groups (e.g. CDISC, PhUSE).
• Contribute and lead functional Continuous Improvement plans, providing strategic direction and identifying essential deliverables that meet timelines, budget, and are with company, departmental requirements.
• Ensure compliance with own Learning Curricula, corporate and GXP requirements.
• Lead and contribute to the development of Clinical Data Standards models (including): CDASH, SDTM, Controlled Terminology, TFLs and questionnaires). Includes periodic assessment of standards content for compliance and industry impacts.
• May lead the assessment, implementation and governance of systems and tools to support on standards
• Lead the development of project plans; determine risks and recommend contingency plans.
• Lead standards compliance review and works with departments and CROs/strategic service providers to strengthen content and interpretation of Takeda standards
• Be a Standards area project manager or team leader for selected standards projects and teams.
• Develop strategy for Standards Management technology selection and deployment across Clinical Studies with established Takeda SOPs and Policies, and governance models.
• Oversee Standards delivery life cycle, including deployment strategies, Communications, User training and management.Educational Qualifications
  • BS/BA required preferably in a health-related, life science area or technology-related fields.Requirements
    • Project management experience managing clinical data standards activities for large drug development programs.
    • Advanced knowledge of broad drug development process with expertise in Data Management & Data Standards.
    • 8 years data standards and drug development process with expertise in the data management function.
    • Experience with budget planning and management.
    • Knowledge of relational databases and experience using multiple clinical data management systems.
    • Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
    • Working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.
    • Working knowledge of clinical trial terminology and Architect Loader Specification
    • Knowledge of XML, ALS and MDRBase Salary Range: $150,000-170,000 based on candidate professional experience level. Employee may also be eligible for Short Term and Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off.If candidate is not eligible for any benefits or other comp., those can be excluded.This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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