Junior Clinical Budgeting & Contract Analyst

Zydus Therapeutics Inc.•Hopewell Township, NJ

12d

About The Position

Position Summary: This role serves as a critical bridge between Clinical Operations, Project Management, Finance, Legal, and Procurement, responsible for developing, negotiating, and managing clinical trial budgets and vendor/site contracts. While the final decision on vendor costing resides with the Finance Director and the Head/VP of Project Management & Clinical Operations, this role ensures that all operational, feasibility, and protocol-driven cost considerations are accurately reflected in budgets and contracts.

Requirements

Bachelor’s degree in Finance, Business, Life Sciences, or related discipline.
2–6 years of experience in clinical trial contracting, budgeting, or vendor management within a pharmaceutical, biotech, or CRO environment.
Experience developing and negotiating CRO, vendor, and site budgets and agreements.
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.
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.
Assist in implementing standard templates, tools, and best practices to drive efficiency and consistency across studies.