Manager, Study Associates
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
The Manager, Study Associates, under the guidance of the Associate Director, will supervise a group of Study Associates (SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
The Manager, Study Associates will ensure the SAs provide clinical administrative support to the study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures. Responsible for staff training, performance management, setting individual employee goals and career growth opportunities.
The Manager, Study Associates will also manage contract staff, as required.
Supervise at team of 10-12 Study Associates
Participate in resume review, interviewing, hiring and onboarding of new staff
As part of Vendor Oversight, meet with contract agencies on a monthly basis to provide performance feedback for contract Study Associates, contract statuses, and discuss project timelines for current and future contract needs
Evaluate employee performance through study team feedback and established performance metrics, and provide this feedback through regularly scheduled 1:1 meetings
Collaborate with Clinical Study Manager on SA deliverables
Participates in departmental and cross-functional process improvement initiatives, as required
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Bachelor's degree required. Master's degree is preferred
5 years relevant experience is required with a BS; 3 years relevant experience with an MS
1-2 years of people management is preferred
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a
Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO); CRA experience is preferred
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.
Manager, Study Associates
Global Clinical Operations & Planning