FSP-(Senior) Clinical Trial Associate-Client Office Based with Flexible Work From Home

Job title: FSP-(Senior) Clinical Trial Associate-Client Office Based with Flexible Work From Home

About the Role The Senior Clinical Trial Associate will support management and execution of clinical trials from the client office base, with flexible work-from-home options. The role focuses on regulatory submissions, TMF maintenance, and operational support to ensure trials stay compliant and on schedule.

What You'll Do

• Prepare / submit clinical trial application dossiers in line with CSM/CRAs, GCP, ICH, local regulations and Global Pharma SOPs; maintain in-house TMF submission documents properly.
• Prepare EC/IRB submissions for new and ongoing trials; translate global English study documents/tools (e.g., informed consent).
• Follow up EC review status, coordinate responses to EC queries, and ensure timely submission.
• Setup and maintain submission dossiers; upload local documents for HA submissions to REDI_AA and submit completed dossiers to HAM.
• Serve as CTA hub contact to support clinical trial supplies management; backup for IMP CPO contact as defined in local SOPs.
• Align with CRAs/CSMs to generate startup plan milestone dates and ensure study milestones (submission/approval, startup, recruitment, closeout) are met.

What We're Looking For

• Strong foundation in clinical trial management; ability to work independently and guide others.
• Demonstrated ability to coordinate, organize, and communicate; basic understanding of clinical development including GCP and ICH.
• Proven ability to work in teams and deliver on commitments.
• At least two years IRB amendment experience; initial submission experience a plus.
• Strong teamwork and internal influence; basic therapeutic area knowledge; communication with EC/HA.

Nice to Have

• IRB amendment experience (2+ years) with initial submission experience preferred.

Compensation & Benefits

• Competitive salary with comprehensive benefits including various annual leave entitlements, health insurance options, retirement planning offerings, and LifeWorks Global Employee Assistance Programme.
• Life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, etc.).