Industry: CRO
Department: Clinical Operations Group
Office Location: Seoul, South Korea
Accountabilities:
- Site Identification & Start-Up – Identify, assess, and select investigators/sites; conduct feasibility, evaluation, and initiation visits; prepare and submit regulatory/Ethics Committee packages; coordinate import/export requirements; negotiate budgets, execute contracts, and ensure timely payments.
- Monitoring & Site Management – Conduct on-site and remote monitoring per plan; verify data quality, resolve queries, and ensure compliance with protocol, ICH/GCP, and safety reporting requirements; track metrics, address issues, and implement risk mitigation strategies.
- Training & Engagement – Train and motivate site personnel to ensure clear understanding of protocol, investigational product, and trial requirements; support recruitment initiatives and maintain strong investigator relationships.
- Documentation & Systems – Collect, review, and approve essential documents; reconcile Trial Master File with site files; maintain trial records in CTMS and other tracking tools; oversee distribution, tracking, and return/destruction of investigational product and supplies.
- Close-Out & Compliance – Perform site close-out visits, archiving, and translation verification as required; ensure all trial activities meet quality, regulatory, and contractual obligations.
- Team Support – Mentor junior staff and perform additional tasks as assigned by line or project management.
Requirements:
- Education & Experience – Tertiary qualifications in a relevant science or healthcare field with clinical trial experience in academic, CRO, or pharmaceutical settings.
- Technical & Regulatory Expertise – Skilled in participant safety, site start-up/conduct, risk and quality management, supply management, clinical research design, and issue escalation; solid knowledge of ICH-GCP, medical terminology, and global/local regulations.
- Business & Analytical Skills – Strong in negotiation, conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
- Communication & Stakeholder Engagement – Excellent interpersonal, presentation, and communication skills; able to work independently and collaboratively across diverse teams and stakeholders.
- Organisation & Adaptability – Strong organisational and time management skills, with the ability to prioritise, take initiative, and adapt to changing priorities.
- Systems & Mobility – Proficient in Microsoft Office Suite and other project management tools; willing to travel as required.
Job Type: Full-time
Pay: 65,000,000원 - 80,000,000원 per year
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