As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites
Job Summary
As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Matching Summary
As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites.
Skills & Requirements
Must-have
Country Submissions management
Investigative site activation
Regulatory submission coordination
Clinical trial documentation accuracy
Site start-up facilitation
Nice-to-have
Team collaboration and expertise sharing
Work-life balance focus
Continuous learning and development
Key Requirements
2+ years clinical research Site Start Up experience
BS degree or international equivalent
Proficient in Microsoft Excel, Word, and PowerPoint
Knowledge of clinical study protocols and essential documents