Execute outsourcing strategies for clinical trials in collaboration with Clinical Development that supports the business needs and maximizes the return on investment.
Lead RFI/RFP processes, vendor evaluations, and bid defense meetings to select CROs, Labs, RTSM, electronic Clinical Outcome Assessments, Blood Pressure Monitoring and other various specialty vendors in collaboration with a cross functional team.
Ensure all outsourcing activities are conducted in a manner that conforms to an ethical process as well as adherence to all applicable internal and external compliance standards, processes and guidelines.
Negotiate and manage MSAs, work orders, and change orders in collaboration with Legal; ensure completeness, accuracy, and appropriate business terms (pricing, deliverables, milestones, payment schedules, and performance measures).
Work cross-functionally to lead and manage special project initiatives such as preferred provider relationships, functional service provider models (FSP), strategic partnerships, standardization initiatives, metrics / KPIs, SOP development and training programs.
Drive standardization and process improvement across vendors to ensure consistency and operational efficiencies
Collaborate with internal team members to manage vendor relationships and to resolve any vendor performance issues.
Partner with Finance to forecast study budgets and manage financial accruals.
Partner with Clinical Operations, Regulatory, Quality, and Finance teams to drive operational excellence and compliance.
Train and educate clinical development and other relevant functional areas on outsourcing activities, processes and requirements
Requirements
Bachelor’s degree in Life Sciences, Business, or related field; advanced degree preferred.
6+ years of experience in clinical outsourcing/vendor management within pharma/biotech or CRO.
Experience in Commercial Sourcing a plus
Proven experience negotiating complex contracts and managing vendor relationships
Knowledge of clinical trial operations, regulatory requirements, and financial management.
Excellent communication, influencing, and problem-solving skills.
Ability to work in a fast-paced, matrixed environment.
Benefits
standard Company benefits including medical, dental, vision, time off and 401K
participating in Mineralys incentive plans are contingent on achievement of personal and company performance