Study Support Specialist (GLP studies – Product Safety Labs)
Core
Support Study Directors in managing GLP-compliant pre-clinical studies, ensuring data quality, regulatory compliance, and on-time delivery of study documentation and results.
Role type
Study Support Specialist (GLP studies)
Builds
Study documentation, data packages, and regulatory-ready records for pre-clinical trials
Domain
Life sciences / Pre-clinical research / GLP compliance
Required skills
GLP regulatory knowledge, study protocol management, data quality control, chain-of-custody tracking, technical writing, risk monitoring, study logistics coordination
Preferred skills
Master's in Pharmacology or Toxicology, experience with IND enabling studies, experience with IND filing
Technologies
Study management systems, document control systems, data tracking tools
Responsibilities
Coordinate study protocols and amendments; conduct quality control reviews of laboratory data and records; monitor study milestones and critical path activities; manage chain-of-custody and shipping documentation; compile study data packages for reporting and regulatory inspection; provide technical writing support for study documents; track deviations and data requests.
Seniority
Mid-level, hands-on specialist
