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Manager, Study Associates

2 months ago

Trenton, United States Daiichi Sankyo Full time

Manager, Study Associates

in

Basking Ridge

at

Daiichi Sankyo

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, 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. Responsibilities 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.

Education Qualifications (from an accredited college or university) Bachelor's Degree Bachelor’s degree required. required Master's Degree preferred Experience Qualifications

4 or More Years years relevant experience is required with a BS required 1 or More Years relevant experience with an MS required 1 or More Years 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 preferred Physical Requirements

In-house office position that may require occasional travel. 10% of Time 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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