- Argentina
- Senior
- 5+ years
Help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
Responsibilities
- Forecasts submission/approval timelines and ensures they are adhered to.
- Prepares ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules.
- Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines.
- Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.
Requirements
- Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional