Clinical Trial Assistant at SAGIMET BIOSCIENCES INC.

Foster City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Oct, 26

Salary

90.0

Posted On

17 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

TMF/eTMF Management, Clinical Trial Operations, Regulatory Documentation, ICH-GCP Guidelines, Site Activation, Document Version Control, Microsoft Office, CTMS, EDC, Quality Control, Clinical Research, Project Tracking

Industry

Pharmaceutical Manufacturing

Description

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

Responsibilities

Provide operational and administrative support for clinical trials, focusing on TMF maintenance and regulatory document tracking. Assist with study start-up, site activation, and close-out activities while collaborating with CROs and internal stakeholders.