Collaborate with lab staff to gather study requirements, test article information, and study design
Conduct quality control reviews of laboratory data, worksheets, and study records to ensure
Monitor study milestones, deliverables, and critical path activities to proactively identify risks
Coordinate the development, review, revision, and issuance of study protocols, amendments, and
Maintain study documentation and tracking systems, ensuring study files remain audit-ready and
Assist with the preparation of shipping documentation and return authorizations for test articles

🎯 Requirements

Master's degree in a science-related field (Pharmacology or Toxicology preferred)
5-7 years of experience in Pre-clinical studies/trials, IND enabling studies, IND filing
Knowledge of regulatory requirements (GLP)
Honest, dependable, demonstrated ability to self-manage
Detail-oriented, accurate, and precise
Strong math skills

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