Senior Clinical Outsourcing and Clinical Budget Manager

Job not on LinkedIn

🕒 Yesterday

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $131.2k - $154.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Miltenyi Biotec

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Miltenyi Biotec is a global biotechnology company that develops and manufactures instruments, reagents, and software for cell separation, flow cytometry, single-cell analysis, and cell and gene therapy research and manufacturing. Its products and services support academic research, translational studies, and clinical manufacturing workflows, enabling isolation, analysis and manipulation of cells for immunology, neuroscience, cancer research and regenerative medicine.

📋 Description

• Lead the Clinical Outsourcing function for Clinical Development North America • Ensure operational excellence across contract and budget activities • Establish individual objectives aligned with Clinical Development goals • Serve as subject matter expert for contract management and service provider budget forecasting • Collaborate with Finance, Clinical Operations, Legal, and external service providers • Own and oversee the contract lifecycle for clinical studies, investigators, CROs, laboratories, consultants, and other service providers • Oversee RFP processes and evaluate and select service providers • Analyze service provider budgets, evaluate bids, and identify negotiation opportunities • Negotiate and manage MSAs, SOWs, and Change Orders • Resolve complex contractual matters with Legal and Clinical Development stakeholders • Review contractual terms, identify risks, recommend mitigation strategies, and protect organizational interests • Develop and maintain contract governance standards, templates, SOPs, and supporting documentation • Support development, review, and approval of clinical trial budgets • Drive annual budget planning and quarterly forecasting for Clinical Development North America • Monitor budget utilization and variance analyses • Provide financial insights and recommendations to Clinical Development leadership • Identify financial risks and opportunities and implement mitigation measures • Oversee budget negotiations with CROs and service providers • Monitor contract and budget performance and escalate issues • Align service provider deliverables and invoicing with contractual obligations • Review financial impacts of scope changes and contractual amendments • Establish and monitor financial and operational KPIs • Deliver management reports on contract status, budget performance, forecast accuracy, service provider spend, and financial risks • Support audits, inspections, and internal reviews • Ensure accurate financial documentation and timely reconciliation of project expenditures • Support review and processing of study-related invoices • Reconcile service provider payments against contractual deliverables and budget allocations • Monitor invoice processing timelines and improve payment efficiency • Ensure adequate regulatory and internal documentation • Streamline processes, improve data quality, and enhance financial visibility • Implement contract and budget management best practices • Contribute to departmental and cross-functional strategic initiatives

🎯 Requirements

• Bachelor's degree or equivalent in related field • 8+ years of previous related experience with Clinical Study Agreements and service provider contracts • Knowledge of supplier qualification processes • Strong legal and clinical knowledge in contract management and clinical research • Experience in clinical trial contracts, budgets, and compliance • Proficiency in contract negotiation, budget development, and regulatory compliance • Experience negotiating contracts, terms, and budgets • Ability to develop and integrate metrics demonstrating the value of clinical contracts to the business • Ability to support and guide team members during contract negotiations • Proven ability to manage competing priorities in a fast-paced environment and adapt to shifting business needs • Ability to interact professionally across organizational levels and influence cross-functional leadership • Ability to organize, coordinate, direct, control, plan, and solve problems • Ability to comprehend and follow instructions • Ability to make quick decisions on complex issues independently • Ability to analyze and interpret data and information • Ability to make decisions using sound judgment • Good eye/hand coordination • Ability to use keyboard, computer, and phone • Regular and predictable attendance • Ability to travel domestically and internationally as required

🏖️ Benefits

• Health, vision, and dental insurance • 401(k) plan • Certain positions may be eligible for additional compensation such as bonuses or commissions • Reasonable accommodations in accordance with applicable law