Immediate opportunity for three (3) remote, Sr Associates, Clinical Contracts & Budgets. The Sr Associate, Clinical Contracts & Budgets provides clinical site contracting services to clinical study teams to support study start up and conduct activities.
Pay Range: Market rate depending on education and experience
Position Length: 1 yr. contract position; extension possible
Essential Duties and 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 Company Payment System (eGPS)
- Support resolution of contract and budget 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 budget for inclusion in the 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
- Support Clinical Pricing & Payments Group in setting up sites for eGPS , ClinCard or 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
Qualitifications:
- Master's degree (MS) OR Bachelor's degree (BS) and 2 years of experience
- Recent (within last 3 years) contract and budget negotiation experience in a clinical trial setting
- Directly involved with the negotiation of terms for various contract types (CTA, CDA, Master Agreements, etc) and site budgets
- Good working knowledge of common software packages (e.g. Office 365 esp. Excel, Word, SharePoint, Microsoft Teams, SAP)
- Attention to detail
- Negotiation skills
- Organizational Skills
- Relationship management
- Time management & prioritization
- Flexibility
- Written and oral communication skills
- Data analysis and presentation skills
- Problem solver
- Team work
