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 packages, data sets, and regulatory-ready reports for pre-clinical trials
Domain
Life sciences / Pre-clinical toxicology and pharmacology
Required skills
GLP compliance knowledge, study protocol management, data quality control, regulatory filing support, chain-of-custody tracking, technical writing, study milestone monitoring
Preferred skills
Master's in Pharmacology or Toxicology, experience with IND enabling studies, strong mathematical and organizational skills
Technologies
Study tracking systems, document management systems
Responsibilities
Coordinate study protocols and amendments; conduct quality control reviews of laboratory data; monitor study milestones and critical path activities; manage study documentation and tracking systems; prepare shipping documentation and chain-of-custody records; compile study data packages for reporting and regulatory inspection; provide technical writing support for study reports
Seniority
Mid-level, hands-on specialist
