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 Database Application and Reporting is a member of the Biostatistics and Data Management Data Operations team and serves as a subject matter expert responsible for the analysis, implementation, support, and maintenance of clinical database applications and reporting. This position reports to the Associate Director/Director, Data Infrastructure Operations. The responsibilities include business process and analysis of new and/or existing applications, technology, and infrastructure; coordination, testing, authoring, and maintaining documentation including requirements, use cases, test scripts, end-user job aids & work procedures; authoring business continuity plans and system SOP/SOIs; maintaining compliance and inspection readiness with systems and supporting processes documentation; and extending operational systems support for Electronic Data Capture (EDC), and Clinical Data Repository (CDR) systems, among others. This position will collaborate with members of Biostatistics and Data Management, Clinical Study teams, IT Service Management, QA, external partners, and other stakeholders.
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
Competencies
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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