Strategic Outsourcing Manager

Full Time, Temporary/Contract/Project, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 2+ to 5 Years Career Level: Manager (Manager/Supervisor of Staff) Company: Devon Consulting Contact: Steven Horner Phone: 610 964 5772 Reference Code: D8545 Strategic Outsourcing Manager Manager, Strategic Outsourcing Management 1. Responsible for implementing medical outsourcing for U.S. Medical Affairs clinical trial and registry work across all therapeutic areas, including vendor management, financial management, and contract development in accordance with quality, time, and cost targets. 2. Responsible for vendor management activities including identifying and evaluating potential vendors, proactively identifying operational and/or relationship issues and resolving issues in a timely manner, and reviewing and validating all business and legal documents including contracts and agreements with CROs/vendors, etc., working in partnership with Purchasing, Legal and Finance departments. 3. Responsible for development and scope of work of multi-service, multi-vendor contracts with high degree of complexity and dollar value. 4. Responsible for specifications for the development and execution of agreements for contract research services with outside vendors/CROs to ensure that the progress of outsourced work through to final acceptance of deliverables is monitored in conjunction with the study management teams. 5. Represent Strategic Outsourcing Management at departmental meetings, including project review, Study Management Team meetings, etc. Collaborate with therapeutic area medical leaders, study teams, Purchasing, Legal, and Finance through the development and implementation of outsourced strategies for all clinical trials ensuring effectiveness and compliance. 6. Provide recommendations and participate in process improvement initiatives within Strategic Outsourcing Management and U.S. Medical Affairs. Skills: · Minimum of 5 years’ experience in clinical research setting within the pharmaceutical industry required. · Minimum of 3 years’ experience and demonstrated proficiency in coordination of clinical drug studies (from initiation to closure), of complex, global nature, multi-indication, multi-drug, including experience with study budget management, clinical project management, and medical outsourcing management. · Ability to work independently with therapeutic area medical leaders, Purchasing, Legal, Finance and study management teams through the development and implementation of all clinical trials and registries. · Excellent networking and communicating skills with multifunctional internal and external partners, ability to work well within a matrix organization; e.g., Medical Affairs, Finance, Purchasing, Legal, Medical Research, externally with key medical leaders, vendors and societies. · Knowledge of applicable FDA, Pharma, OIG, and allied association guidelines and regulations. The ability to quickly acquire and apply the Company regulatory policies and SOPs, ensuring all projects are in compliance with applicable policies and SOPs; the ability to quickly access further reference information on these guidelines to answer specific questions. · Demonstrated ability to achieve budgetary results and the effective allocation of internal/external resources Education: · Bachelor’s degree in health-related, business and/or finance-related field. Advanced degree is preferred. Please send resumes to Steven Horner at Shorner@devonconsulting.com   Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants