Manager/ Senior Manager- Clinical Budgeting & Contract
8 days ago
Pennington
Job DescriptionDescription: Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, saroglitazar, is a dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). As a wholly owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. The opportunity to empower people with the freedom to live healthier and more fulfilling lives is what makes a career with Zydus Therapeutics so rewarding. Our team is collaborative, innovative and adaptable. We are action-oriented and strive for excellence in all we do, all underpinned by respect, trust and integrity. We offer a wide variety of competitive benefits, services and support programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives If you are passionate about helping bring potential life-changing discoveries to patients, then you share our mission. 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., • 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., • Partner with Clinical Operations, Project Managers, Legal, Finance, QA, and Procurement to align on contract terms and ensure timely internal approvals., • 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 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: Required Qualifications & Experience • 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.