Senior Associate Clinical Contracts & Budgets

Purpose:

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

Context:

• Amgen K.K. office
• Reports to CTOM (Clinical Trial Oversight Manager)

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

• Contracting processes in applicable countries
• Payment processes in applicable countries

Competencies

• Attention to detail
• Negotiation skills
• Numeracy skills
• Organizational skills
• Relationship management
• Time management and prioritization
• Flexibility
• Written and oral communication skills
• Language skills: local languages and English
• Good working knowledge of common software packages
• Data analysis and presentation skills
• Problem solver
• Teamwork