Senior Clinical Outsourcing and Clinical Budget Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Direct the Clinical Outsourcing function for Clinical Development in North America.

• Ensure excellence in operations related to contracts and budget management.

• Set individual objectives that align with the goals of Clinical Development.

• Act as a subject matter expert in contract management and service provider budget forecasting.

• Collaborate effectively with Finance, Clinical Operations, Legal, and external service providers.

• Manage and oversee the entire contract lifecycle for clinical studies, investigators, CROs, laboratories, consultants, and other service providers.

• Supervise the RFP processes and assess and select service providers.

• Analyze service provider budgets, assess bids, and identify opportunities for negotiation.

• Negotiate and manage MSAs, SOWs, and Change Orders.

• Resolve complex contractual issues in conjunction with Legal and Clinical Development stakeholders.

• Review contract terms, identify potential risks, recommend strategies for risk mitigation, and safeguard organizational interests.

• Develop and maintain governance standards, templates, SOPs, and documentation for contracts.

• Assist in the development, review, and approval of clinical trial budgets.

• Lead annual budget planning and quarterly forecasting for Clinical Development in North America.

• Monitor budget utilization and carry out variance analyses.

• Provide financial insights and recommendations to the leadership of Clinical Development.

• Identify financial risks and opportunities and implement appropriate mitigation strategies.

• Oversee budget negotiations with CROs and service providers.

• Monitor the performance of contracts and budgets, escalating issues as necessary.

• Ensure alignment of service provider deliverables and invoicing with contractual obligations.

• Review financial impacts related to scope changes and contractual modifications.

• Establish and track financial and operational KPIs.

• Deliver management reports detailing contract status, budget performance, forecast accuracy, service provider expenditures, and financial risks.

• Support audits, inspections, and internal reviews.

• Ensure accurate financial documentation and timely reconciliation of project expenditures.

• Assist in the review and processing of study-related invoices.

• Reconcile service provider payments with contractual deliverables and budget allocations.

• Monitor timelines for invoice processing and enhance payment efficiency.

• Ensure proper regulatory and internal documentation is maintained.

• Streamline processes, improve data quality, and enhance financial visibility.

• Implement best practices in contract and budget management.

• Contribute to strategic initiatives at both the departmental and cross-functional levels.

⛳️ Requirements

• Bachelor's degree or equivalent in a related field.

• Over 8 years of relevant experience with Clinical Study Agreements and service provider contracts.

• Understanding of supplier qualification processes.

• Strong legal and clinical expertise in contract management and clinical research.

• Experience with clinical trial contracts, budgets, and compliance requirements.

• Proficient in contract negotiation, budget development, and regulatory compliance.

• Experience in negotiating contracts, terms, and budgets effectively.

• Ability to develop and implement metrics that demonstrate the value of clinical contracts to the organization.

• Capacity to support and guide team members during contract negotiations.

• Proven ability to manage competing priorities in a fast-paced environment and adjust to changing business needs.

• Ability to interact professionally at all organizational levels and influence cross-functional leadership.

• Skills in organizing, coordinating, directing, controlling, planning, and problem-solving.

• Ability to comprehend and follow instructions accurately.

• Capability to make quick decisions on complex issues independently.

• Proficient in analyzing and interpreting data and information.

• Capacity to make informed decisions using sound judgment.

• Good eye/hand coordination skills.

• Proficient in using a keyboard, computer, and phone.

• Regular and predictable attendance is required.

• Willingness to travel domestically and internationally as needed.

🏝️ Benefits

• Health, vision, and dental insurance.

• 401(k) plan.

• Certain positions may qualify for additional compensation such as bonuses or commissions.

• Reasonable accommodations will be provided in accordance with applicable law.