Sr. Clinical Affairs Specimen Operations Specialist
Core
Leads planning and execution of specimen logistics for clinical studies, ensuring supply, sample handling, and data flows support study designs and evidence generation.
Role type
Senior Clinical Affairs Specimen Operations Specialist
Builds
Clinical study programs and evidence generation pipelines
Domain
Healthcare diagnostics and clinical research
Required skills
specimen logistics, clinical trial operations, supply chain management, project management, cross-functional coordination, regulatory compliance (FDA/ICH GCP), process improvement, data analysis, risk management, stakeholder alignment
Preferred skills
process and workflow design, CAPM certification, global regulatory knowledge, clinical systems functionality
Technologies
clinical systems, project management tools
Responsibilities
Lead operational planning and strategic management of specimen logistics; translate study requirements into actionable specimen operations plans; manage and analyze key specimens and supply performance metrics; problem-solve and resolve specimen and logistics issues; lead continuous process improvement; provide guidance and coaching to less-experienced team members
Seniority
Senior, hands-on IC with mentorship responsibilities