Clinical Affairs Specimen Operations Manager
Core
Manage logistical setup, supply and sample management, and process improvement for internal and external clinical studies in oncology.
Role type
Manager, Clinical Affairs Specimen Operations
Builds
Clinical study logistics and sample management infrastructure for commercial and pipeline oncology products
Domain
Life Sciences / Oncology / Clinical Research
Deliverable
client delivery
Required skills
Project management, cross-functional stakeholder liaison, process improvement, metrics definition and reporting, supply chain coordination, regulatory compliance knowledge
Preferred skills
Process and workflow design, CAPM certification, FDA regulations and ICH GCP knowledge
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Responsibilities
Develop operational relationships with cross-functional teams (Clinical Labs, Regulatory, R&D), lead small to medium projects, coordinate supply and sample management setup, liaise between internal and external stakeholders, visualize and document processes, define and report on study health metrics, manage project schedules and action items
Seniority
Manager, hands-on IC
