Manage ethics committee submissions and regulatory compliance
Oversee vendor activities and study budgets
This role serves as the primary point of contact to lead, manage, and coordinate clinical trials at a country level in accordance with ICH-GCP and local regulations
Job Summary
This role serves as the primary point of contact to lead, manage, and coordinate clinical trials at a country level in accordance with ICH-GCP and local regulations.
The successful candidate will be accountable for compiling and submitting necessary documentation to ethics committees and managing regulatory directives such as EU CTR and IVDR.
You will actively collaborate with global and local teams to drive study progress, ensure timely delivery, and maintain the scientific integrity of clinical trial results.
Matching Summary
This role serves as the primary point of contact to lead, manage, and coordinate clinical trials at a country level in accordance with ICH-GCP and local regulations.
Skills & Requirements
Must-have
Lead clinical trials from start-up to close out
Manage ethics committee submissions and regulatory compliance
Oversee vendor activities and study budgets
Ensure ICH-GCP and local regulation adherence
Drive site evaluation and selection processes
Nice-to-have
Build strong investigator site relationships
Lead cross-functional local study teams
Conduct on-site quality visits with CRAs
Facilitate resolution of cross-functional issues
Maintain therapeutic knowledge in biotech
Key Requirements
Doctorate degree OR Master's degree with 3 years experience
Bachelor's degree with 5 years directly related experience
7 years work experience in life sciences or medically related field
4 years of biopharmaceutical clinical research experience