What are the responsibilities and job description for the Manager, Study Associates position at Daiichi Sankyo, Inc.?
Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.
Job Summary
The Study Associate Manager , 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 SA Manager 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 SA Manager 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.
- In-house office position that may require occasional travel.
Qualifications:
Education Bachelor’s degree required. Master’s degree is preferred
Experience
- 5 years relevant experience is required with a BS; 3 years relevant experience with an MS
- 1-2 years of people management is required.
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.
Competencies
Advanced oral and written communication skills.
Identifies and resolves problems and escalates issues appropriately
Demonstrates advanced knowledge of processes related to clinical studies, regulatory issues, CRO operations, and compliance practices
Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).
Effectively manages information, data, related analyses, forms and reports
Effectively multi-tasks different assignments and responsibilities.
Proficient with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook.
Travel:
- 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.
