Senior Clinical Trial Associate
Hybrid · Taipei, Taiwan, Taiwan
Job Summary
Prepare / submit EC/IRB submission dossiers for new and ongoing clinical trials in compliance with GCP, ICH, local regulations, and Global Pharma SOPs. Key responsibilities include preparing EC/IRB submissions, translating study documents/tools (e.g. Informed consent), following up EC review status, coordinating responses to EC queries, setting up and maintaining submission dossiers, serving as CTA hub for uploading local documents for HA submission, and potentially backing up IMP CPO contacts for trial supplies. Align with CRAs/CSMs to generate startup milestone dates and ensure milestones (submission/approval, startup, recruitment, closeout) are met, while delivering independent and collaborative trial management support.
Required Qualifications
- Two years IRB amendment experience
- Ability to coordinate, organize and communicate
- Basic understanding of clinical development process including GCP and ICH fundamentals
- Experience working on teams and delivering commitments
- Initial submission experience (nice to have)
- Strong teamwork and internal influence
- Basic Therapeutic area knowledge
- Eligibility to work in the country where the role is based
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