Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements
Job Summary
Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries.
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
Matching Summary
Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
Skills & Requirements
Must-have
Sponsor SOPs and WIs adherence
Regional clinical trial oversight
End-to-end project management
ICH-GCP and local regulations
Health Authority inspection participation
Nice-to-have
Strategic site recruitment planning
Patient safety and informed consent review
Excellent decision-making skills
Strong financial management skills
Key Requirements
BA/BS degree in health or science
Minimum 2 years local/regional trial management
Previous experience as Clinical Research Associate