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
Masters degree OR
Bachelors 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