Senior Clinical Outsourcing and Clinical Budget Manager *PC 1637
Miltenyi Biotec

Your Role:

The Senior Clinical Outsourcing Manager is responsible for the strategic oversight, governance, and operational execution of all clinical trial contracts and budgets within Clinical Development North America.

The position serves as the key business partner to Clinical Operations, Finance, Legal, and external service providers to ensure contracts and budgets are negotiated, executed, monitored, and controlled in accordance with business objectives, regulatory requirements, and project timelines.

Essential Duties and Responsibilities:

• Lead the Clinical Outsourcing function for Clinical Development North America and ensure operational excellence across all 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 various stakeholders across the organization, including finance, clinical operations, and legal, to ensure smooth communication and effective project management.

Contract Management & Governance

• Own and oversee the contract lifecycle process for clinical studies, investigators, CROs, laboratories, consultants, and other service providers.
• Oversee the Request for Proposal (RFP) processes, ensuring thorough evaluation and selection of service providers.
• Conduct comparative analysis on service provider budgets to evaluate bids and identify negotiation opportunities.
• Negotiate and manage contracts, including Master Service Agreements (MSAs), Statements of Work (SOWs), and Change Orders.
• Collaborate with Legal and Clinical Development stakeholders to resolve complex contractual matters.
• Review and evaluate contractual terms, identify risks, recommend mitigation strategies, and ensure organizational interests are protected.
• Develop and maintain contract governance standards, templates, SOPs, and supporting documentation.

Budget Planning & Financial Oversight

• Partner with Clinical Operations to support the development, review, and approval of clinical trial budgets at study, country, site, service provider, and portfolio levels.
• Drive annual budget planning and quarterly forecasting processes for Clinical Development North America.
• Monitor budget utilization and variance analyses, ensuring budget performance aligns with approved plans.
• Provide financial insights and recommendations to support strategic decision-making by Clinical Development leadership.
• Identify financial risks and opportunities and implement mitigation measures as appropriate.

Service Provider Financial Management

• Oversee budget negotiations with CROs, service providers, and service providers to ensure cost-efficient outsourcing strategies.
• Monitor contract and budget performance of external service providers and escalate issues where necessary.
• Partner with Clinical Operations to ensure service provider deliverables and invoicing activities are aligned with contractual obligations.
• Review financial impacts of scope changes and contractual amendments.

Financial Controls & Reporting

• Establish and monitor relevant financial and operational KPIs for clinical development projects.
• Deliver regular management reports on contract status, budget performance, forecast accuracy, service provider spend, and financial risks.
• Support audits, inspections, and internal reviews related to contract and budget management activities.
• Ensure accurate financial documentation and timely reconciliation of project expenditures.

Invoice Management & Compliance

• Partner with Clinical Operations to support the review and processing of study-related invoices.
• Ensure appropriate reconciliation of service provider payments against contractual deliverables and budget allocations.
• Monitor invoice processing timelines and drive continuous improvements in payment efficiency.
• Assure adequate documentation for regulatory and internal purposes.

Continuous Improvement

• Identify opportunities to streamline processes, improve data quality, and enhance financial visibility.
• Implement best practices related to contract and budget management.
• Contribute to departmental and cross-functional strategic initiatives within Clinical Development.

Requirements:

• Bachelor's degree or equivalent in related field; 8+ years of previous related experience with Clinical Study Agreements and Service provider contracts along with 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 in negotiations for contracts, terms, and budgets.
• Ability to develop and integrate metrics that demonstrate the value of clinical contracts to the business.
• Provide support and guidance to team members during contract negotiations to identify optimal solutions.
• Proven track record of managing competing priorities in a fast-paced environment and adapting to shifting business needs.
• Ability to interact professionally across all organizational levels and influence cross-functional leadership to gain alignment.

Physical and Mental Demands:

• Ability to organize/coordinate
• Direct, control and plan solve
• Problem Solve
• Perform with frequent interruptions

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