Senior Manager, Clinical Outsourcing

Employment Type

: Full-Time


: Non-Executive Management

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Description The Senior Manager, Clinical Outsourcing leads and manages activities related to the outsourcing of clinical services including negotiation, and maintains contracts for Clinical Research Organizations (CROs) and functional service providers for the Neurology Business Group (NBG). This person will manage the processes, which support the implementation and management of global clinical outsourcing. The Senior Manager, Clinical Operations will foster clear, consistent and open collaboration with Leading Pharmaceutical / Biotech Company and service provider staff to ensure the most optimal solutions are achieved. This person will also engage in service provider relationship and performance management and participate in continuous improvement initiatives, which quicken or provide efficiencies in achievement of Leading Pharmaceutical / Biotech Company goals. Essential Functions: 1. The Senior Manager, Clinical Outsourcing is responsible to: a) Support NBG in the development of outsourcing requirements for Phase I-IV global clinical trials including functional services. b) Lead and support the qualification and evaluation process for new service providers. c) Lead the process of Request for Proposal (RFP) development from service provider selection through final contract execution. d) Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments. e) Negotiate services descriptions, budgets and payment schedules using costing tools as necessary f) Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets. g) Support project teams in the resolution of service-provider performance issues. h) Facilitate or attend lessoned learned meeting as necessary to incorporate improvements in new projects. i) Manage assigned service provider relationships ensuring issue resolution and efficient outcomes, as applicable. j) Monitor outsourcing environment to keep current on providers and industry trends. 2. Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts. 3. Maintain central database for contract tracking purposes, workload management, and metrics tracking. 4. Identify best practices; lead the development and implementation of new processes for the department and other tasks that may be required to accomplish departmental goals and objectives. 5. Manage and/or mentor junior members of staff in outsourcing processes and in the review / QC of work as necessary. Qualifications BA/BS in scientific or business discipline required. Direct experience (8 yr. minimum) in managing clinical vendor contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants, etc. Demonstrates business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO). Skills and aptitude required: Must have excellent written and oral communication skills. Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others. Flexible and proactive. Excellent analytical and problem solving skills. Eye for detail. Highly organized with strong negotiation skills. Must have good leadership and project management skills. Thorough knowledge of GCP/ICH Guideline and Regulations. Clear understanding of the drug development process. Displays independent thinking and good judgment. Proficiency in MS Office Suite

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