* Manages operational functions including, supervising other staff who contribute to clinical contract management.
* Participates in establishing departmental and cross-functional policies and procedures
* Impacts the business results of related teams by setting priorities, allocating resources, and developing policies and plans
* Is accountable for the performance and results of a team
* Interprets, executes and recommends modifications to operating policies and procedures
* Adapts group plans and priorities to address resource and operational challenges
* Accountable for developing talent through on-going performance feedback and career management coaching
* Is an expert in category management and had a history of devolving category roadmaps or sourcing plans
* Develops global clinical development vendor strategy for a program or therapeutic areas
* Manages contract and sourcing activities for clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation
* Develops and implements sourcing strategies to support given scope
* Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings
* Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory
* Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis)
* Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate
* Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area
* Is an SME in resolving complex issues relating to contract negotiation and management
* Oversees the identification, selection and management of global external service providers
* Leads Vendor bid defense meetings
* Manages the contract negotiation process for complex or high value contracts
* Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development
* Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives
* Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices
* Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement
* Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders
* Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up
* Engage with clinical operations leadership to drive sourcing strategy, compliance, and continued partnership
* Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance
* Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management
* Manages study level vendor relationships in conjunction with Clinical Operations
* Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements
* Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations
* Pulls data across functions according to business requirements and recommends global development vendors to senior leadership for endorsement for a project
* Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols
* Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members
* As necessary, trains internal stakeholders in contract budgeting, development, and administration
* Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management
* Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions
* Financial acumen to review, analyze and understand cost drivers of complex budgets
* Legal, clinical operations and regulatory acumen
* Travel may be required
Knowledge, Experience and Skills:
* Relevant experience with a BA or MS in a relevant discipline
PMP/CPSM certification or equivalent a plus
Top Required Skill Sets:
* CRO full-service outsourcing & contract management experience
* Clinical Development
* Stakeholder management & critical thinking
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