Sr. Manager, Outsourcing and Vendor Governance (Office Hybrid or Remote)

As a Sr. Manager, Outsourcing and Vendor Governance team member, you will be responsible for managing outsourcing needs for current and future Phase I to IV clinical trials, including vendor identification, RFPs, vendor selection, contract and budget negotiations, budget management, audit readiness, and supporting the vendor governance process. You will work closely with the Clinical Operations study team, Legal, Finance, and other key internal stakeholders to resolve vendor contract and business-related issues. This role will report to an Associate Director in Outsourcing and Vendor Governance. Responsibilities:

• Manages the clinical outsourcing activities with CROs and other ancillary clinical service providers.
• Independently manage all outsourcing activities including (but not limited to) - supplier assessment, RFP/RFQ/RFI, selection, contract budget, payment schedule, payment terms & scope negotiation through to contract execution and contract life cycle management.
• Manage global clinical development agreements (work orders, amendments, CDAs/NDAs, ancillary, single-service, HCP agreements, and subcontractor agreements).
• Negotiate new and amended work specifications, budgets, payment schedules, payment terms, ensure service providers adhere to contract terms and conditions.  
• Guide project teams through the sourcing process and give appropriate suggestions and advice on the best approach/industry best practices.
• Partners with study team members to manage supplier bidding and proposal development (RFP creation and bid analysis). Facilitates and manages supplier bid defense meetings and associated follow-up.
• Leads contract related communication with suppliers. Respond to questions from internal stakeholders. Interact with suppliers on standard contract terms. Appropriately escalates issues and conflicts.
• Demonstrate expanded understanding of procurement/strategic sourcing principles and supplier selection criteria.
• Demonstrate expanded understanding of legal language to lead contract review and negotiation.
• Identify and manage contract risks. Ensures appropriate mitigation plans are in place and communicate risks to stakeholders.
• Provide information to stakeholders and management on contract statuses and contract/finance issues.
• Ensure agreements comply with company requirements regarding risk assessment and liability.
• Responds and resolves complex issues associated with contracts with support from the appropriate department(s).
• Establishes and manages supplier relationships in conjunction with Clinical Development functions, and other internal departments, as required, including participation in financial health meetings.
• Develop and manage tools to analyze changes between contract versions and change orders.
• Measures and reports service provider outsourcing task-related performance using metrics and KPIs to ensure compliance against agreed upon expectations such as timelines, cost, and quality (e.g., cycle time between joint review meeting and delivery of bid).
• Assist/Lead in the development, improvement, and implementation of processes and tools related to outsourcing activities.
• Support internal and external outsourcing process training.
• Support audit-readiness efforts.
• Use outsourcing systems in compliance with expectations and enter data in a timely manner.
• Manage purchase order process in support of Clinical Development stakeholders and functions.
• Support and manage general and ad-hoc projects as required.
• May be responsible for administrative tasks in support of new vendor onboarding.
• Direct supervision and/or provide mentorship and guidance to colleagues within the function/department.

 Qualifications:

• B.A./ B.S. is highly preferred.
• At least 8+ years equivalent related business/ industry experience.
• Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations).
• Experience in Life Science, Finance, Strategic Sourcing, and/or Business Strategy.
• Solid understanding of drug development process including outsourcing for Phase I to IV clinical trials in a global setting.
• Experience in RFP development, proposal evaluation, and contract and budget management.
• Must be an initiative-taker with minimal supervision.
• Exhibit high self-motivation and ability to work and plan independently as well as in a team environment (virtual or in person).
• Work with cross-functional team members and facilitate communication with internal/external stakeholders.
• Excellent organizational and time management skills to accomplish multiple tasks efficiently and effectively in a demanding environment.
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