Job Summary

The Senior Manager, Clinical Outsourcing, will lead and manage with minimal supervision activities related to the outsourcing of clinical services including negotiation, and maintenance of contracts for Clinical Research Organizations (CROs) and functional service providers for the Oncology or Neurology Business Group. This role will foster clear, consistent and open collaboration with The company and service provider staff to ensure the most optimal solutions are achieved. This individual will engage and lead service provider relationships to support performance management and will be responsible for participating in and leading continuous improvement initiatives, which quicken or provide efficiencies in achievement of The company goals.

Essential Functions

• Support the development of outsourcing requirements for Phase I-IV global clinical trials including functional services. Lead and support the qualification and evaluation process for new service providers. Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution. Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments. Negotiate services descriptions, budgets and payment schedules using costing tools as necessary. Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets. Support project teams in the resolution of study specific service provider performance issues. Facilitate or attend lessoned learned meetings as necessary to incorporate improvements in new projects. Manage assigned service provider relationships ensuring successful start-up and efficient outcomes, as applicable. Monitor outsourcing environment to keep current on providers and industry trends. 60%
• Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts. 10%
• Maintain central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary. 10%
• Identify areas for improvement and lead implementation of new department processes and other tasks that may be required to accomplish departmental goals and objectives. 10%
• Mentor junior members of staff in outsourcing or other functions providing guidance on key processes. Regular QC contract documents as necessary. 5%
• Act as subject matter expert or category lead for specified service areas. 5%

Requirements

• BA/BS in scientific or business discipline required.
• Direct experience (5-7 years minimum) in managing clinical 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).
• 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 with an eye for detail.
• Strong understanding of financial and compliance standards.
• Able to work with minimal supervision.
• 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