Clinical Outsourcing Consultant

As a Clinical Outsourcing specialist my goal is to support Biotech and Biopharma clients with the right knowledge, decision making, and tools at the right time, and where needed, up-skill those organizations to be self-sufficient in the future. With extensive experience gained from building and leading Clinical Outsourcing functions on a global basis for over 25 years, I provide consulting services on all aspects of Clinical Outsourcing including the following areas: - CRO and ancillary provider selection - Identifying the right outsourcing model - Full-Service Outsourcing (FSO) vs Functional Service Provision (FSP) models - RFI, RFP & RFQ design and execution - Scorecard implementation - Bid defense meeting facilitation - Negotiation preparation, planning, and practice - MSA negotiation - Custom vs CRO bid grids - Rate card benchmarking and negotiation - Bonus, penalty, incentive, and earn back structures - Budget models (unitized, fixed price/fixed scope, outcomes based) - Payment schedules (unitized vs time & materials vs milestone based) - Preferred provider / strategic partnership models - Supplier governance and oversight models - CROs managing third party providers - Financial oversight and reporting - Accruing labor costs, grants, and other passthroughs - Foreign exchange and inflation - Early termination of clinical programs - Switching CROs - Sourcing emerging technologies and solutions such as DCTs, DEI, and AI. - Clinical site contracting and FMV assessment - ICH GCP considerations for Clinical Outsourcing - Vendor selection, qualification and oversight SOPs - Procurement policies - Design of Clinical Outsourcing organizations - Sourcing & selection of Clinical Outsourcing staff