Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
Job Summary
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.
Matching Summary
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Skills & Requirements
Must-have
ICH-GCP compliance
protocol compliance
site qualification and initiation
monitoring visits
case report form (CRF) verification
query resolution
Investigator Site File (ISF) review
Nice-to-have
drug development mindset
problem solvers
agile and driven to deliver
inclusive culture
adapt to changing priorities
Key Requirements
Bachelor’s degree or RN in a related field
Knowledge of Good Clinical Practice/ICH Guidelines