Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Provide support and oversight to local vendors as applicable. Interacts with EC and Regulatory...
Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our companyโs policies and procedures, quality standards and adverse event reporting requirements...
Drug & Non-Drug Supply Management. Payment and Invoice Management. Document & report checks from Veeva. Preparation of submissions to regulatory authorities. Management of safety documents. Pre and Post Monitoring Visit...
Performs clinical study sitemanagement/monitoringactivities in compliance with Good Clinical Practice and associated documents & regulations,. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out,....
Performs clinical studysite management/monitoring activitiesin compliance with Good Clinical Practice and associated documents & regulations,. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out,....
Work allocation, staff development and performance appraisal. Provides input for capacity planning, including reporting of current manpower and forecasting of - CRA capacity and needs, to provide efficient use of...
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Provide support and oversight to local vendors as applicable. Interacts with EC and Regulatory...