Job Description:
• Execute outsourcing strategies for clinical trials in collaboration with Clinical Development that supports the business needs and maximizes 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:
• medical
• dental
• vision
• time off
• 401K
• participating in Mineralys incentive plans contingent on personal and company performance