
201 - 500 employees
🏭 Manufacturing
💼 Consulting
📦 Logistics
Manufacturing • Consulting • Logistics
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.
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201 - 500 employees
🏭 Manufacturing
💼 Consulting
📦 Logistics
Manufacturing • Consulting • Logistics
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.
• Prepare, review, negotiate, and manage Clinical Trial Agreements, amendments, and study budgets with sponsors and investigative sites • Facilitate CTA and amendment review and execution with Sponsor, Site, and Ora legal teams • Develop and review clinical trial budgets, including per-patient costs, start-up fees, pass-through expenses, and overhead • Track contract milestones, renewals, and amendments throughout the study lifecycle • Monitor budget approvals and align contract terms with negotiated budgets • Define payment terms, invoicing schedules, and milestone payments in contracts • Analyze study protocols for cost implications and fair market value • Prepare reports on contract status, budget approvals, and payment status • Collaborate with global cross-functional teams including Project Management, Clinical Trial Associates, Clinical Research Associates, Project Directors, and IT • Collaborate with Legal on contract negotiations • Track data integration between EDC and Veeva Vault, identify data issues, and follow up on issues causing payment delays • Set up, process, and manage clinical trial site payments in Veeva Vault Payment in accordance with CTAs and approved budgets • Verify payment triggers before payment • Calculate and reconcile per-patient payments, start-up fees, milestone payments, and pass-through expenses • Ensure payments are issued accurately and on schedule • Reconcile payments with invoices, supporting documentation, and financial systems • Identify and resolve overpayments, underpayments, and payment discrepancies • Provide support and guidance to Site Contract & Payment team members • Adhere to Ora’s quality system, data integrity, business ethics, and regulatory requirements
• Associate’s or Bachelor’s degree in business or Life Sciences, with one or more years’ experience in clinical research or equivalent combination of education, training and experience; years of experience may be considered in lieu of education • 2+ years’ experience in clinical research administration, contracts, or budget negotiation • High attention to detail and ability to manage multiple studies simultaneously • Clinical trial contract negotiation, budget development, and cost analysis experience • Experience working at a research site or in a CRO environment • Knowledge of clinical trial agreements and research billing • Experience in clinical site payments and clinical trial operations • Strong analytical and communication skills • Strong organizational skills and commitment to high-quality work • Experience with Adobe, Excel spreadsheets, Microsoft Word, and Outlook • Knowledge of GCP/GXP/ICH regulations • Ability to set goals, create structure, and deliver timely, high-quality work • Ability to work as an agile, positive, authentic, transparent, resilient, empathetic, and collaborative communicator • Ability to give and receive feedback and resolve conflicts
• Comprehensive medical, dental, and vision healthcare options beginning day 1 • Flexible PTO • Unlimited sick time • 14 company-paid holidays • 401(k) plan through Fidelity with company match • Adoption assistance • Fertility assistance • 16 weeks paid parental leave • Company-paid life insurance • Company-paid disability insurance • Remote workspace reimbursement • Wellness reimbursement • Employee Assistance Program • Career development opportunities • Opportunities to work with colleagues across the globe • Opportunity to research new ophthalmic therapies with global patient impact
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