About the role
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