Sr Site Start-up Associate II (Medical)

TL;DR

Sr Site Start-up Associate II (Medical): Managing the regulatory and operational start-up of clinical trial sites for biotech and medtech companies with an accent on regulatory submissions and site contract negotiations. Focus on ensuring ICH/GCP compliance, coordinating with local authorities (EC/IRB), and optimizing the timeline for study initiation.

Location: Hybrid (Taiwan)

Company

hirify.global is a leading CRO helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and diagnostics.

What you will do

• Prepare and submit Central/Local EC/IRB and RA applications and other regulatory authority submissions.
• Negotiate site-specific contracts and budgets, ensuring resolution of issues and timely execution.
• Conduct site identification and eligibility screening by contacting investigators.
• Maintain Trial Master File (TMF) accuracy and perform QC reviews in line with the File Management Plan.
• Provide country-level regulatory intelligence and guidance on data protection compliance.
• Liaise with internal teams, clients, and vendors to ensure start-up tasks meet contracted timelines.

Requirements

• Undergraduate degree in a clinical, science, or health-related field.
• 5+ years of related experience, including at least 3 years in clinical trial application submissions.
• Expertise in ICH/GCP, ISO14155, and local regulatory authority drug research and development regulations.
• Experience with various study types, including interventional IMP, Medical Device, and observational studies.
• Fluent English and fluency in the host country language.
• Must be based in Taiwan.

Culture & Benefits

• Flexibility and balance to support individual life requirements.
• Opportunities for professional growth and skill development.
• Collaborative environment where employee ideas influence internal workflows.
• Meaningful work contributing to life-saving medical innovations.