Senior Associate Clinical Contracts & Budgets

Purpose

Provide clinical site contracting services to clinical study teams to support study start up and conduct activities

Context and Responsibilities

Location:
•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

Role Qualifications, Knowledge & Competencies

Qualifications
•Master’s degree OR
•Bachelor’s degree
Experience
•Relevant experience in Legal, Negotiation and/or Finance
•Working in a global environment
•Matrix environment
Knowledge
•Knowledge of local contracting processes in applicable countries
•Knowledge of local payment processes in applicable countries
•Business English and local language