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.