Clinical Trial Assistant

Description

The Clinical Trial Assistant (CTA) provides operational and administrative support to the Clinical Operations team in the execution of Sagimet’s clinical trials. This role requires a highly organized, detail-oriented individual who can manage multiple priorities and contribute across a broad range of clinical and regulatory activities. The CTA will play a hands-on role in trial start-up, maintenance, and close-out activities, partnering closely with Clinical Trial Managers (CTMs),, vendors, and cross-functional internal stakeholders. The CTA will report to the Senior Vice President, Clinical Operations.

Essential Responsibilities:

• Maintain,  organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times
• Assist with study start-up activities, including collection and tracking of regulatory documents (e.g., 1572s, CVs, licenses, IRB/EC approvals)
• Support site activation, maintenance, and close-out processes
• Track and manage clinical trial documentation, ensuring accuracy, completeness, and timeliness
• Assist with creation, review, and formatting of study-related documents (protocols, manuals, study plans, etc.)
• Prepare or oversee CRO with clinical trial materials including investigator site binders, study tools, and training materials
• Assist CRO and internal team with oversight of sample tracking vendor and dashboard. 
• Track operational deliverables, timelines, and key milestones
• Assist in organizing investigator meetings, vendor meetings, and internal study team meetings
• Draft meeting agendas, capture meeting minutes, and follow up on action items
• Maintain study tracking tools and spreadsheets (e.g., site lists, enrollment trackers, document trackers)
• Support review of data entry and reconciliation activities across systems (e.g., CTMS, eTMF, EDC where applicable)
• Assist in the preparation of status reports and dashboards for internal stakeholders
• Ensure compliance with GCP, SOPs, and applicable regulatory requirements
• Support audit and inspection readiness activities, including documentation preparation and QC
• Assist in tracking and filing safety reports and regulatory submissions
• Provide administrative support to the Clinical Operations team as needed
• Manage document version control and filing systems
• Support cross-functional collaboration with Regulatory, Quality, and Clinical Development
• Other duties as assigned

Requirements

Education and Experience Requirements:

• Bachelor’s degree in life sciences, healthcare, or related field preferred 
• 2–4 years of experience in clinical research, clinical operations, or a related field 
• Experience in a biotech, pharma, or CRO environment preferred; startup experience a plus
• Strong organizational skills with exceptional attention to detail 
• Ability to manage multiple tasks and prioritize effectively in a fast-paced environment 
• Excellent written and verbal communication skills 
• Proficiency with Microsoft Office (Word, Excel, PowerPoint); familiarity with CTMS/eTMF systems preferred 
• Understanding of ICH-GCP guidelines and clinical trial processes