Outsourcing Manager

Position Purpose

The Outsourcing Manager (OM) is an integral member of the Clinical Business Operations team within Clinical Development (CD). The OM is responsible for implementing and executing a TA or FA specific contracting and outsourcing strategy that will optimize clinical program / study delivery and costs utilizing a consistent teamwide approach and methodology.

Main Responsibilities And Accountabilities

Develop, lead and implement short-term and long-term TA and FA specific outsourcing strategies liaising with key Clinical Development stakeholders to identify potential needs, improve efficiencies and strengthen the sponsor strategic Contracting and Outsourcing approaches to best practice level. This includes all elements of outsourcing: identifying potential vendors, vendor assessment, contract negotiation and execution, and governance activities. Oversee the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors, including but not limited to central laboratories, systems vendors, niche suppliers and consultants and will work with CD global teams in the selection of niche vendors and specialized consultants through defined processes (which may include Request for Information, Request for Proposal, or other Due Diligence activities).Create operational cost modeling and scenario planning to support build versus buy decisions utilizing both internal & external inputs as required. Compile and analyze into cohesive recommended strategies and present to appropriate management teams.Work across CBO, Contracts Managers, Outsourcing Managers, Governance Manager, Clinical Outsourcing Specialists and other Clinical Development stakeholders to ensure that processes and tools are followed to monitor contractual obligations and responsibilities, as outlined in global CD initiated Master Service Agreement/ Contract/ Consultancy Agreement/ Work Orders, and that they are tracked and upheld, ensuring the sponsor remains protected and in compliance with contractual obligations at all times. Ensure that new project work is efficiently and effectively communicated to the sponsors external service providers, including review of RFPs and RFQs prepared by Clinical Outsourcing Specialists and addressing questions raised by vendors in the preparation of quotations or proposals.Work with the cross functionally within Clinical Business Operations, the Business Operations Management, Business Performance Management, Global Project Leads and other key Clinical Development personnel to ensure that vendor spend in support of global Clinical Development programs is in compliance with the negotiated MSA/contractual terms and rate cards and within approved forecasts and budgets.Ensure that any contractual terms agreed are understood by relevant Clinical Development and Legal responsible individuals so that the Company and its vendors meet their legal obligations. This includes helping the Responsible Person (related to a contract) understand and carry out his/her responsibilities.In collaboration with Business Performance Management support the systems and processes in place to effectively manage and monitor business relationships with critical vendors and ensure they deliver as required. This will be done by participating in a tiered vendor governance structure including project teams, operational governance, and executive committees as defined by Business Performance Management.Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions. Support all End-to-End CBO Processes to drive operational efficiencies.

Education

Degree (Bachelors) in a Business related and /or scientific/medical/pharmaceutical discipline, preferably combined with relevant clinical trial experience with a business focus.

Experience

Minimum 4 years clinical outsourcing and/or external service provider management with a CRO and or Pharmaceutical company.Must have a comprehensive understanding of clinical development processes and management of clinical studies including cost structures.Strong understanding of contracts and legal terms.