Clinical Contracts

4 weeks ago

Thousand Oaks, United States Randstad Life Sciences US Full time

Immediate opportunity for eight (8) 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

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