Purpose:

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

　　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 experienceKnowledge

　　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