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.
Summary
The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy.
Responsibilities
Study Planning and Execution:
CRO and Quality Oversight:
Knowledge Management:
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
Experience Qualifications:
Travel:
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.
Description Position at Seagen Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As...
Apply For This JobJob Description Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics...
Apply For This JobJob Description Responsible for directing the development and execution of the plant site mission, vision, and objectives. Assures primary and...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> IT Technician I The IT Technician I serves as the first line of response to...
Apply For This JobAbout the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led...
Apply For This JobDescription Position at Seagen Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As...
Apply For This Job