Specialist II, PK Sample Management (BioAnalytical Systems Analyst)

Responsibilities: Track and coordinate clinical investigational PK site shipments to ensure timely deliveries while meeting quality and regulatory requirements. Work cross-functionally with Clinical Operations to support clinical programs with PK sample management requirements. Assist in preparation and tracking of global logistics for Reference Standards and PK sample movements. Collect and organize PK sample documents to support filing into the electronic Trial Master File (eTMF) system. Review and summarize PK sample temperature recorder data to ensure timely archiving and correct TMF indexing. Manage PK sample long-term storage. Assist in drafting or revising PK and sample management SOPs. Communicate with external vendors and internal customers as needed. Support non-clinical PK logistics as needed. Preferred Skills/Qualifications/Technical Proficiencies: Excellent interpersonal communication (verbal and written), strong organizational skills, and ability to prioritize within timelines. Strong attention to detail and proactive follow-up. Ability to interpret written or verbal instructions. Comfortable in a fast-paced small development company environment. Proficient in Microsoft Outlook, Word, and Excel. Preferred Education and Experience: High school degree with at least 5 years of related experience; or bachelor's degree with at least 3 years. Additional qualification/experience in PK sample management. Knowledge of GxPs and familiarity with US/EU regulations. Knowledge of the drug development process. Experience with IRT systems and other databases. Experience with Microsoft Office applications (e.g., Pivot charts), Lucid chart, Swimlane, and Smartsheet. #J-18808-Ljbffr Scorpion Therapeutics