1 year Contract REMOTE Purpose / Accountabilities Provide clinical site contracting services to clinical study teams to support study start up and conduct activities 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 systemsSupport 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 Must Haves: 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.
We want to make sure they are not just a "middle man" passing the contract from clinical trial site/sponsor to legal.The following 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, Word, SharePoint, Microsoft Teams, SAP)?Data analysis and presentation skills?Problem solver?Team work Red Flags No contract negotiation experienceNo (or very little) experience with clinical trial contractsBackground in supply chain management/payments onlyContract experience heavily leans on administrative side (execution, filing, tracking – not negotiation)Last clinical contracting experience -3 years agoLack of stable work history (1-2 month assignments with significant gaps)