Position Title: Study Start-Up Jr. Specialist / Specialist (1Position)
Division: PDG CCO (Product Development Global Country Clinical Operation)
Work Location: Seoul, South Korea
Main Responsibilities and Accountabilities:
- Updates Knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
- Executes all start up activities prior to site activation.
- Prepare country level ICF
- Obtains local regulatory authorities' approval (IND & IRB)
- Maintain and analyze study start-up metrics ensuring optimal efficiency to reduce timelines and identify opportunities for continuous improvement
- Partners with other stakeholders to provide guidance on regulatory/ethics requirements
- Supports drug label preparation and approval for studies in collaboration with local regulatory/quality department, as required.
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/laws, via innovative approaches
- identifies and tracks new investigator sites performing feasibility and supports effective patient recruitment retention practices as required.
- Responsible for study budget and contract negotiation and ensures compliance with Fair Market Value in the country.