Clinical Contracts and Outsourcing Manager

Reporting to the Senior Director, the Clinical Contracts and Outsourcing Manager will be accountable for the development, negotiation, review, and lifecycle management of global Phase I-IV clinical CRO, vendor, site and related ancillary contracts and the management of 3rd party functional service providers/vendors involved in the contract management process.

Responsibilities: 

• Negotiates directly with CROs and vendors for clinical trial services optimal pricing
• Manages contract activities for multiple Oncology clinical development programs.
• Responsible for management of all global clinical development agreements - clinical research/investigator, confidentiality, ancillary and vendor master service agreements, single-service, and subcontractor agreements
• Identifies and manages contracts risks. Ensures appropriate mitigation plans are in place and in use and risks are communicated appropriately to stakeholders
• Provides information to stakeholders and management on contract statuses and contract/finance issues
• Responds and resolves complex issues associated with domestic and international contracts with support from the appropriate department(s) 
• Assists staff working on contracts in resolving complex issues relating to contract negotiation or management:
  • Establishes and manages vendor relationships in conjunction with Clinical Operations, and other internal departments as required
  • Establishes a robust performance management process and ensures vendor/supplier performance is understood and measured (e.g., cost control, complexity reduction, simplification, best practice procurement)
  • Ensures agreements comply with company requirements, regarding risk assessment and liability
  • Partners with relevant staff to manage vendor/supplier bidding and proposal development (RFP creation and bid analysis). Coordinates and manages vendor bid defense meetings and associated follow-up.
  • Leads contract life cycle management process related to vendor/supplier and collaborative agreements
  • Develops and implements policies, procedures and standardized tools based on identified needs.

Qualifications:

• BA/BS degree in business or related field
• 4+ years’ clinical contract negotiation experience within pharma/biotech required
• Comprehensive experience with Request for Proposal process, evaluation/comparison of proposals, bid analysis and strong negotiation skills 
• Mentoring/training experience is a plus
• Strong understanding of regulatory and legal issues pertinent to clinical contracts
• Excellent analytical and customer service skills essential