Sr Site Start Up Associate II (Clinical Research)

TL;DR

Sr Site Start Up Associate II (Clinical Research): Managing the regulatory and administrative start-up process for clinical trials with an accent on regulatory submissions and site activation. Focus on coordinating with local authorities and investigators to ensure ICH/GCP compliance and timely study launch.

Location: Taiwan

Company

hirify.global is a clinical research organization helping biotech, medtech, and specialty pharma companies transform science into new medicines and devices.

What you will do

• Prepare and submit regulatory applications (EC/IRB, RA) and resolve country-level issues.
• Manage ongoing submissions, amendments, and periodic notifications, including safety reporting.
• Collect and review essential documents to ensure compliance with ICH/GCP and local regulatory requirements.
• Negotiate site-specific contracts and budgets with investigators and sponsors.
• Conduct site identification and eligibility assessments for clinical trial protocols.
• Maintain Trial Master File (TMF) accuracy and provide country-level regulatory intelligence.

Requirements

• Undergraduate degree in a clinical, science, or health-related field.
• Must be based in Taiwan to handle local regulatory and site activities.
• 5+ years of related experience, including at least 3 years in clinical trial applications.
• Expertise in ICH/GCP, ISO14155, and Taiwan local regulatory requirements.
• Fluent English (C1) and fluency in the host country language (Chinese).
• Experience with interventional IMP, Medical Device, GMO, and observational studies.

Culture & Benefits

• Support for professional growth and skill development.
• Work environment that values employee voice and ideas.
• Focus on flexibility and work-life balance.
• Opportunity to contribute to life-saving medical innovations.