Career Category

Job Description

 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