Clinical Contracts and Outsourcing Manager

Location
Remote or Hayward , California
Posted
Mar 26, 2021
Ref
193
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

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