Senior Clinical Outsourcing and Clinical Budget Manager PC 1637
About The Position
The Senior Clinical Outsourcing Manager is responsible for strategic oversight, governance, and operational execution of clinical trial contracts and budgets within Clinical Development North America. The role partners with Clinical Operations, Finance, Legal, and external service providers to ensure that contracts and budgets are negotiated, executed, monitored, and controlled in line with business objectives, regulatory requirements, and project timelines. The position leads the Clinical Outsourcing function, sets objectives aligned with Clinical Development goals, and serves as a subject matter expert in contract management and service provider budget forecasting. It oversees the lifecycle of clinical study contracts and related RFPs, negotiations, financial planning, forecasting, performance monitoring, invoicing, reporting, compliance, and process improvement. The role also provides financial insights to Clinical Development leadership, supports audits and inspections, and helps ensure accurate documentation and reconciliation of project expenditures.
Requirements
- Bachelor's degree or equivalent in a related field.
- At least 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 with 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 that demonstrate the business value of clinical contracts.
- Proven ability to manage competing priorities in a fast-paced environment and adapt to changing business needs.
- Ability to interact professionally across organizational levels and influence cross-functional leadership to gain alignment.
Responsibilities
- Lead the Clinical Outsourcing function for Clinical Development North America and ensure operational excellence across contract and budget activities.
- Establish individual objectives aligned with Clinical Development goals.
- Serve as a subject matter expert for contract management and service provider budget forecasting.
- Collaborate with Finance, Clinical Operations, Legal, and other stakeholders to support communication and project management.
- Own and oversee the contract lifecycle for clinical studies, investigators, CROs, laboratories, consultants, and other service providers.
- Oversee Request for Proposal (RFP) processes, including evaluation and selection of service providers.
- Compare service provider budgets to evaluate bids and identify negotiation opportunities.
- Negotiate and manage Master Service Agreements (MSAs), Statements of Work (SOWs), and Change Orders.
- Work with Legal and Clinical Development stakeholders to resolve complex contractual matters.
- Review contractual terms, identify risks, recommend mitigation strategies, and protect organizational interests.
- Develop and maintain contract governance standards, templates, SOPs, and supporting documentation.
- Partner with Clinical Operations to develop, review, and approve clinical trial budgets at study, country, site, service provider, and portfolio levels.
- Drive annual budget planning and quarterly forecasting for Clinical Development North America.
- Monitor budget utilization and variance analyses against approved plans.
- Provide financial insights and recommendations to support strategic decisions by Clinical Development leadership.
- Identify financial risks and opportunities and implement mitigation measures as appropriate.
- Oversee budget negotiations with CROs and service providers to support cost-efficient outsourcing strategies.
- Monitor external service provider contract and budget performance and escalate issues when necessary.
- Work with Clinical Operations to align service provider deliverables and invoicing with contractual obligations.
- Review the financial impacts of scope changes and contractual amendments.
- Establish and monitor financial and operational KPIs for clinical development projects.
- Deliver 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.
- Ensure accurate financial documentation and timely reconciliation of project expenditures.
- Partner with Clinical Operations on 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 documentation for regulatory and internal purposes.
- Identify opportunities to streamline processes, improve data quality, and enhance financial visibility.
- Implement best practices in contract and budget management.
- Contribute to departmental and cross-functional strategic initiatives within Clinical Development.
- Provide support and guidance to team members during contract negotiations to identify optimal solutions.
- Travel domestically and internationally as required.
Benefits
- Health insurance
- Vision insurance
- Dental insurance
- 401(k) plan
- Certain positions may be eligible for additional compensation such as bonuses or commissions
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What This Job Offers
Job Type
Full-time
Career Level
Senior
