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 Site Contracts and Budget Management (SCBM) group develops strategy and provides oversight to all studies in compliance with internal processes and external requirements for the following area in the study start up space – Investigator Site Contracts, Budgets and Site Payment processes. The current process is supported by CRO partners and the SCBM group is required to build an effective collaboration with our strategic alliance partnership and a process for appropriate oversight of any outsourced or contracted activities utilizing both performance and quality measurements.
The Manager, SCBM position provides site contracts and site budget related support and oversight for phase I- IV clinical trials. The Manager, SCBM is responsible for providing program, study, and site level support for the full lifecycle of a clinical trial, providing planning, budget and site contract strategy, escalation and resolution of contract and budget management issues including Fair Market Value (FMV) deviations requests, oversight of timely and accurate site payments, and oversight of the CRO deliverables to ensure complaint and timely execution of site contracts and budgets. The position is responsible for adherence to all processes and guidelines along with the CRO relationship management with a specific focus on site contracts and site budgets.
The position may take on other site contracts and budget related activities to ensure smooth and efficient functioning of the site contracts and budgets process area. Activities may include but not limited to direct site budget build (without CRO involvement) and/or direct negotiation of site contracts and/or Master Clinical Trial Agreements (MCTA). Support may also extend to Scientific Research Collaborations.
Business needs within the group may require this role to take on an increased focus on one or more of the above areas or even additional related areas to ensure Global Clinical Operations (GCO) goals are met.
Responsibilities:
Provide consistent and effective site contract and budget strategy, oversight, and support to clinical trials by taking on the following responsibilities:
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.
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