Manager/ Senior Manager- Clinical Budgeting & Contract

Zydus Therapeutics Inc.•Hopewell Township, NJ

15h

About The Position

Description Key Responsibilities Contracting & Negotiation Draft, review, and negotiate Master Service Agreements (MSAs), Work Orders (WOs), Clinical Trial Agreements (CTAs), Confidentiality Agreements, and Amendments with CROs, vendors, and investigative sites. Ensure contract language aligns with operational requirements, timelines, deliverables, and risk mitigation. Budget Development & Financial Planning Develop, compile, and validate study-level budgets including site budgets, CRO budgets, vendor budgets, milestone schedules, pass-through costs, labs, imaging, clinical supplies, and ancillary services. Conduct feasibility cost assessments and scenario analyses to guide vendor selection and negotiation strategies. Ensure budgets correctly reflect protocol requirements, visit schedules, assessments, and country-specific regulatory and operational nuances. Cross-Functional Coordination Partner with Clinical Operations, Project Managers, Legal, Finance, QA, and Procurement to align on contract terms and ensure timely internal approvals. Maintain all contract and budget documentation in central systems (CTMS, SharePoint, contract management system). Financial Oversight & Reporting Verify all study-related invoices (CRO, vendors, sites, labs, imaging, logistics etc) against signed contracts, work orders, milestone completion, and project-level deliverables before routing to PM/Finance. Maintain centralized invoice trackers within Project Management to monitor submission status, milestone alignment, aging, and pending clarifications. Identify and flag discrepancies, over-billing, or non-contracted charges; coordinate with Project Managers and vendors to resolve issues prior to Finance escalation. Track and review study spend vs. operational budgets based on project progress. Provide clear financial visibility to Project Managers and leadership during project review meetings, governance reviews, and operational updates. Ensure all invoice-related documentation, approvals, and milestone validations are audit-ready and aligned with internal SOPs and sponsor oversight requirements. Process Governance & Compliance Ensure contracting and budgeting processes comply with ICH-GCP, internal SOPs, and relevant regulatory expectations. Support audit/inspection readiness by providing documentation and responding to audit queries related to contracts and financial records. Implement standard templates, tools, and best practices to drive efficiency and consistency across studies. Train Clinical/Project teams on budget and contract processes, templates, and negotiation fundamentals.

Requirements

Bachelor’s degree in Finance, Business, Life Sciences, or related discipline.
3–6 years of experience in clinical trial contracting, budgeting, or vendor management within a pharmaceutical, biotech, or CRO environment.
Proven experience developing and negotiating CRO, vendor, and site budgets and agreements.
Strong financial acumen including budget modelling, variance analysis, forecasting, and invoice reconciliation.
Solid understanding of clinical trial operations and cost drivers (e.g., monitoring, procedures, assessments, visit schedules, labs).
Familiarity with ICH-GCP, local/global regulatory practices, compliance standards, and clinical financial governance.
Excellent communication, negotiation, and cross-functional coordination skills.

Responsibilities

Draft, review, and negotiate Master Service Agreements (MSAs), Work Orders (WOs), Clinical Trial Agreements (CTAs), Confidentiality Agreements, and Amendments with CROs, vendors, and investigative sites.
Ensure contract language aligns with operational requirements, timelines, deliverables, and risk mitigation.
Develop, compile, and validate study-level budgets including site budgets, CRO budgets, vendor budgets, milestone schedules, pass-through costs, labs, imaging, clinical supplies, and ancillary services.
Conduct feasibility cost assessments and scenario analyses to guide vendor selection and negotiation strategies.
Ensure budgets correctly reflect protocol requirements, visit schedules, assessments, and country-specific regulatory and operational nuances.
Partner with Clinical Operations, Project Managers, Legal, Finance, QA, and Procurement to align on contract terms and ensure timely internal approvals.
Maintain all contract and budget documentation in central systems (CTMS, SharePoint, contract management system).
Verify all study-related invoices (CRO, vendors, sites, labs, imaging, logistics etc) against signed contracts, work orders, milestone completion, and project-level deliverables before routing to PM/Finance.
Maintain centralized invoice trackers within Project Management to monitor submission status, milestone alignment, aging, and pending clarifications.
Identify and flag discrepancies, over-billing, or non-contracted charges; coordinate with Project Managers and vendors to resolve issues prior to Finance escalation.
Track and review study spend vs. operational budgets based on project progress.
Provide clear financial visibility to Project Managers and leadership during project review meetings, governance reviews, and operational updates.
Ensure all invoice-related documentation, approvals, and milestone validations are audit-ready and aligned with internal SOPs and sponsor oversight requirements.
Ensure contracting and budgeting processes comply with ICH-GCP, internal SOPs, and relevant regulatory expectations.
Support audit/inspection readiness by providing documentation and responding to audit queries related to contracts and financial records.
Implement standard templates, tools, and best practices to drive efficiency and consistency across studies.
Train Clinical/Project teams on budget and contract processes, templates, and negotiation fundamentals.