Manager, Clinical Outsourcing

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

The Manager, Clinical Outsourcing will manage key activities related to the outsourcing of clinical trials with a particular emphasis on vendor outsourcing (Clinical Research Organizations) and contract and financial management of clinical service providers across multiple studies and global programs within Clinical Development. 

Essential Duties & Responsibilities

  • Lead RFP process (including vendor evaluation and vendor selection) for clinical service provider needs (CROs and other clinical vendors) for new clinical studies of various phases and sizes and complexity and risk. Includes assessing vendor capabilities, as well as leading the study teams through the process of analyzing complex budget scenarios, bids, and outsourcing models to determine best value and best fit.
  • Manage and lead contract and financial negotiations with external clinical service providers (specific focus on CROs) including analysis of complex, detailed scopes of work, exhibits, payment terms, significant budgets, MSAs and Change Orders for assigned studies/programs.
  • Serve as primary point of contact to the CROs and clinical vendors in resolving contract scope and financial issues for assigned studies/programs/vendors and managing and escalating issues accordingly.
  • Manage review and negotiation of contract business terms and partner with Legal, Finance and other internal stakeholders as needed to finalize terms. Ensure compliance with required corporate financial approval policies. 
  • Partner with clinical study leads and team members to create specifications for work to be outsourced; determine and assess candidate vendors based on capabilities, capacity, strategic fit, expertise, quality, performance and price.
  • Manage vendor relationships and oversee vendor performance (including financial relationship management) to ensure compliance against contracted services for outsourced work and escalate issues as appropriate.
  • Manage vendor financials for assigned studies/programs/vendor relationships including negotiation of payment terms and schedules, invoice review, tracking of unit utilization based on contracted activity, tracking of Purchase Order utilization to budget/plan, escalation and resolution of payment issues, and manage vendor Business Review meetings as needed.
  • Evaluate and optimize/enhance key business processes and establish best practices with internal and external stakeholders and business relationships and represent Outsourcing in process initiatives.  
  • Ensure timely study execution in support of corporate and department goals within financial plan.
  • Provide oversight of vendors to ensure management of the project’s scope, contract, and finances; ensure that any contractual changes in scope are communicated, negotiated, documented, and transparently proportional to actual activity or incurred cost.
  • Drive Outsourcing process improvement efforts
  • Maintain current awareness of clinical outsourcing industry trends and contribute to process improvement and new process development.

Core Competencies, Knowledge and Skill Requirements

  • Must have strong analytical, negotiating and business communication skills
  • Must be self-motivating and be able to prioritize and manage a large volume of work, handle a moderate amount of pressure, and show attention to detail
  • Proficient with word processing, spreadsheet and database software, and clinical and financial systems.
  • Experience and confidence working with multiple functional areas and facilitating communication across multiple levels of internal/external teams.

Communication & Interpersonal Skills

  • Excellent interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.

Education  

  • Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals) or Business Degree (or equivalent)

Experience  

  • 5+ years of experience in clinical research environment or comparable applicable experience; understanding of clinical terminology, business practice, process, timeline and key budget drivers
  • Previous experience working with CROs and other key clinical service providers
  • Procurement expertise (clinical research or services)
  • Contract management and negotiation experience required (budget and business terms and conditions)
  • Proven ability to build and maintain effective internal and external relationships
  • Sound background in financial/controlling issues