Job title: clinical trials management lead
* provides operational leadership and strategic oversight of safety processes, content, and data quality within clinical studies.
key responsibilities:
* safety operational processes: develops, implements, and manages safety operational processes for clinical trials, including protocols, icfs, crfs, safety management plans, study forms, csrs, and tools.
* training requirements: develops training requirements and materials for clinical trial safety data reporting and collection.
* clinical trial safety report collection: supports the collection of safety reports from investigators and collaborates with other functions to ensure consistency with regulations and study objectives.
* quality review: leads the quality review of icsrs and oversees the kpis pertaining to data quality.
* root cause analysis: leads data quality-related root cause analysis, qe investigation, and capa management.
* safety data review: reviews and analyzes safety data from clinical studies and supports ongoing safety surveillance activities.
requirements:
* a minimum of a bachelor's degree in a biological or natural science, or healthcare discipline.
* eight (8)+ years of pharmacovigilance and gcp experience required.
* extensive experience in case processing, handling of icsrs, and submissions/exchanges in both clinical trial and post-marketing settings required.
* hands-on experience in supporting nda/bla/maa filings and responses to health authorities queries required.