Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Manager, Clinical Data Standards, is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the Daiichi Sankyo R&D pipeline by managing activities associated with standards development, management, and implementations for DS Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional stakeholders to optimize data collection services for Daiichi Sankyo Programs. The position will also help in defining standards collection and mapping data definitions thereby ensuring alignment with industry (CDISC) standards for Health Authority regulations. Working knowledge of various data types, data collection methods (EDC & Non-EDC), and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, etc.) for data submissions and relative processes is a must.
Demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment are some of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data Tabulation Model (SDTM), excellent verbal/written skills, analytical, and interpersonal skills for working effectively with people at different levels are also some of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to developing clinical data collection tools.
Responsibilities
Leadership, Direction, and Strategy:
Project Management:
Functional Expertise:
Operational Efficiency / Continuous Improvement:
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
Work Experience
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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