Junior Clinical Budgeting & Contract Analyst at Zydus Therapeutics Inc.

Hopewell Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Mar, 26

Salary

0.0

Posted On

10 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Contracting, Negotiation, Budget Development, Financial Planning, Cross-Functional Coordination, Financial Reporting, Process Governance, Compliance, Communication, Vendor Management, Clinical Trial Operations, Cost Assessments, Regulatory Practices, Audit Readiness, Documentation, Risk Mitigation

Industry

Pharmaceutical Manufacturing

Description

Description 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. ________________________________________ 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 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. • 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. • Assist in implementing standard templates, tools, and best practices to drive efficiency and consistency across studies. Requirements Required Qualifications & Experience • 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. ________________________________________ Working Relationships Reports to: • Head of ZTI or Head / VP – Project Management & Clinical Operations Regular Interactions with: • Clinical Project Managers • Finance & Procurement • Legal, QA, and Vendor/Site Leads

Responsibilities

The Junior Clinical Budgeting & Contract Analyst is responsible for developing, negotiating, and managing clinical trial budgets and vendor/site contracts. This role ensures that all operational, feasibility, and protocol-driven cost considerations are accurately reflected in budgets and contracts.