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 15,000 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.
JOB SUMMARY
The Manager, Laboratory Data Management, is accountable for delivery of clinical lab data management services for assigned programs, collaborating with program teams, CROs and other vendors, and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize lab result collection, cleaning, and reporting technology, processes, and standards. This position may manage multiple programs concurrently. This position will manage lab data analyst resources of assigned studies.
This position requires strong technical skills in working with clinical laboratory data from local and central laboratories. This position requires solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. This position requires a demonstrated ability to manage/lead people and a variety of projects concurrently. Additionally, this position possesses working knowledge of clinical lab data collection and reporting, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.
Responsibilities
Leadership, Direction, and Strategy:
Project Management:
Functional Expertise:
Study Start-Up
Study Conduct
Study Closure
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
Additional requirements
Lab Certifications:
Work Experience
Competencies
Knowledge
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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