Clinical Contracts & Outsourcing Manager
Locations: Remote, United States | Hayward, California | Brisbane, California
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.
- Negotiates directly with CROs and vendors (drug supply, comparator, IRT, central labs, sample management etc.) 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.
- 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