Sr. Outsourcing Associate, Clinical Outsourcing

Role Overview

The Sr. Outsourcing Associate, Clinical Outsourcing is responsible for supporting business aspects of vendor and site agreements across defined clinical service providers and other outsourcing needs for current and future clinical trials. Responsibilities include contract negotiations, budget management, contract quality control through the support the Clinical Operations, Biometrics and Medical Affairs departments in the oversight of service provider performance. This position reports to either the Sr. Dir, Clinical Outsourcing or to the Associate Director of Clinical Outsourcing.

Key Responsibilities

• Supports the preparation and tracking of site agreements.
• Monitors Progress of contract negotiation and execution and providers regular updates to all stakeholders
• Creates effective partnerships with vendors to cultivate and support long term relationships
• If applicable, negotiation of Clinical Trial Agreements and site budgets with US and Canadian sites
• Oversight of third-party negotiations of global Clinical Trial Agreements / Site Budgets
• Assists with vendor governance activities as needed
• Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance
• Maintenance of Clinical Outsourcing team Outsourcing Plans, Timelines and Processes
• Effectively communicates, develops and cultivates operationally excellent internal cross-departmental and external vendor relationships to enable advancement of clinical development programs
• Negotiates change orders and ensures vendors adhere to contract terms.
• Assists with the generation of Request for Information (RFIs), Request for Proposal (RFPs), and assists Clinical Operations, Biometrics or Clinical Development with the service provider selection process including bid comparison analysis, bid defense coordination and leadership of proposal review meetings
• Oversight and execution of contract lifecycle management for assigned clinical studies, vendors and/or program(s)
• Supports the identification, development, improvement and implementation of processes and tools related to outsourcing activities
• Key contributing member of the Clinical Outsourcing team

Minimum Qualifications

• Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered
• 3-5+ years of related experience in a Biotech or Pharma