About this role
Career Category
Clinical DevelopmentJob Description
Purpose
Provide clinical site contracting services to clinical study teams to support study start up and conduct activities
Context and Responsibilities
Location: Bucharest
•Local office or field based role in the affiliate or in the Hub
Reports to:
•CTOM
Responsibilities:
•Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).
•Support site-related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System (eGPS)
•Support resolution of contract issues
•Support contracting with local GSO vendors
•Maintain contract tracking in appropriate systems
•Manage Confidential Disclosure Agreement process
•Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
•Ensure payments are made in accordance with contracts
•Maintain payment data tracking in appropriate systems
•Responsible for providing information for entry into systems
Key Activities
Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution
•Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final Schedule A for addition to contract
•Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance
•Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems (eFinity, MyBuy, SAP). Support Clinical Pricing & Payments Group in setting up sites for eGPSor legacy systems.
•Track contract progression using appropriate systems
•Amend and terminate contracts as necessary throughout lifecycle of study
•Store and archive contracts and budgets in appropriate systems
•Maintain payment records and provide assistance with audit review records
•Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2.
•Responsible for the contracting process and/or point-of-contact for vendor for locally outsourced studies
•Responsible for the Clinical Trials Insurance process
•Participate in appropriate site/legal meetings as required to resolve contract issues
•Participate in appropriate site/finance meetings as required to resolve payment issues
•Maintain party information and contract activation in Contract Generation System
•Approve or reject clinical invoices
•Process and track Confidential Disclosure Agreements as appropriate
•Manage contracting process with Clinical Trial Related Consulting Agreements
•Manage all study-related Site payments not managed by Clinical Pricing & Payments Group
Other facts
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
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What you'll do
- Manage the end-to-end process for clinical site contracts and consulting agreements, including negotiation and resolution of contract issues. Ensure compliance with Fair Market Value and maintain contract tracking and payment records.
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