Senior Associate Clinical Contracts
hace 6 meses
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us
**Purpose**:
Provide clinical site contracting services to clinical study teams to support study start up and conduct activities
**Local office or field based role in the affiliate or in the Hub**:
**Responsibilities**:
- Lead end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, issue, translation, distribution, signature, archiving).
- Support site-related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System (GPS)
- Support resolution of contract issues
- Support contracting with local GSO vendors
- Maintain contract tracking in appropriate systems
- Handle Confidential Disclosure Agreement process
- See opportunities and standard processes with local and regional partners that will give 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
- Handle contracting process with Clinical Trial Related Consulting Agreements
- Handle contracting process with Clinical Trial Related Consulting Agreements
- Lead all study-related Site payments not handled by Clinical Pricing & Payments Group
**Qualifications, Knowledge & Competencies**
- 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
**Key Competencies**
- Attention to detail
- Negotiation skills
- Organizational Skills
- Relationship management
- Time management & prioritization
- Flexibility
- Written and oral communication skills
- Good working knowledge of common software packages (e.g. Office 365 esp. Excel, SAP)
- Data analysis and presentation skills
- Problem solver
- Team work
**Thrive**:
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, nationa
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