As a Sr. Manager, Outsourcing and Vendor Governance team member, you will be responsible for managing outsourcing needs for current and future clinical trials, including vendor identification, RFPs, vendor selection, contract and budget negotiations, budget management 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 is currently reporting to the Director/Senior Director, Outsourcing and Vendor Governance.

Responsibilities

• Manages the clinical outsourcing activities (CROs and other key clinical service providers)
• Independently manages 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
  • Responsible for management of all 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 staff regarding status of contracts. Interacts with suppliers on standard contract terms. Appropriately escalates issues and conflicts.
• Demonstrates expanded understanding of procurement/strategic sourcing principles and supplier selection criteria
• Demonstrates expanded understanding of legal language to lead contract review and negotiation

• Identifies and manages contract risks. Ensures appropriate mitigation plans are in place and in use and risks are communicated appropriately to stakeholders
• Provides information to stakeholders and management on contract statuses and contract/finance issues

• Ensures 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

• Partner with project leads/team members to manage service provider relationships and to oversee service provider performance including financial relationship management to ensure compliance with contracted services for outsourced work
• Develops and manages tools to collect and analyze contracted plan to actual performance to assess changes in service provider scope
• Prepares monthly management reports on service provider’s financial performance including analysis and explanation for key variance drivers, as appropriate
• Measures and reports quarterly service provider performance using metrics and KPIs to ensure compliance against agreed upon expectations such as timelines, cost, and quality
• Assist/Lead in the development, improvement and implementation of processes and tools related to outsourcing activities including a database for identifying and maintaining current and potential service providers
• Manages purchase order process in support of Clinical Development stakeholders and functions
• Supports and manages general and ad-hoc projects as required
• May be responsible for administrative tasks in support of new vendor onboarding
• Direct supervision and/or provides mentorship and guidance to colleagues within the function/department

Qualifications

• A./ B.S., and/ or combination of 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 clinical trials in Phase 1 through 4 in global setting
• Experience in RFP development, proposal evaluation, and contract and budget management
• Must be a self-starter with minimal supervision
• Ability to work with cross functional team and facilitate communication with internal/external stakeholders.
• Ability to work with people across varying levels of responsibility within the company and with service providers
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to analyze and synthesize information to understand issues, identify options and support sound decision making
• Excellent computer skills including advance knowledge in use of MS Excel, Word, PowerPoint, and Outlook.
• Strong organizational and written communication skills with attention to detail
• Able to multi-task and prioritize in a fast-paced environment
• Execute time-sensitive matters while maintaining accuracy, attention to detail, and confidentiality
• Exhibits high self-motivation and ability to work and plan independently as well as in a team environment
• High degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with others, including excellent interpersonal skills
• Displays sound business judgement and proactive, independent work style
• Exercises independent judgement in methods, techniques, and evaluation of criteria for obtaining results
• Works well independently and cooperatively with other to achieve common goals in a virtual environment
• Ability to develop and maintain strong internal and external relationships
• Ability to travel, including overnight stays