Senior Associate Clinical Contracts & Budgets in Tokyo, Japan

Job Information

Purpose:

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

Context:

Live

What you will do

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)
Supports resolution of contract issues
Supports contracting with local GSO vendors
Maintains 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 include but are not limited to

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.
Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance
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
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
Process and track Confidential Disclosure Agreements as appropriate
Manage contracting process with Clinical Trial Related Consulting Agreements

Win

What we expect of you

Basic qualifications:

Master’s degree OR Bachelor’s degree
Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred qualifications:

Finance administration, accounting or contracting or other relevant work experience

Knowledge

Competencies

Apply Now