Clinical Trial Manager

Sagimet Biosciences Inc.; San Mateo (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Sagimet Biosciences Inc. is seeking a Clinical Trial Manager to lead day-to-day trial activities, oversee CROs and vendors, and ensure feasibility and site selection across global studies.

The role focuses on timeline management, study plans, data management conduct, IND updates, and regulatory compliance, requiring strong leadership and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent.
• 10+ years clinical operations experience.
• 3+ years leading clinical trials from start-up to database lock.
• Experience across global Phase 2/3 startup, treatment, and DB lock.
• Experience with central lab start up and oversight.
• Knowledge of data privacy and GDPR guidelines.
• Independent CRO/vendor oversight.
• Experience with double blind/placebo studies.
• Strong analytical skills and attention to detail.

Responsibilities

• Clinical operations lead and main contact with CROs, vendors, and sites.
• Assist in protocol, ICF, and study plan development/review.
• Foster collaboration among internal teams and external vendors.
• Participate in Clinical Operations meetings.
• Review data for trends and quality against protocol and contracts.
• Oversee Trial Master Files and ICH-GCP compliance.
• Track patient recruitment and site status.
• Support yearly IND updates (IBs, DSUR).

Skills

Clinical operations

Vendor management

Project management

Data analysis

Regulatory knowledge

FDA/ICH-GCP

Cross-functional leadership

Phase 2/3 trials

Education

Bachelor’s degree in Life Sciences

Tools

EDC

IXRS

TMF management

Clinical data management

Job description

Description

The Clinical Trial Manager manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables. Additional responsibilities include Independent oversight of outsourced clinical studies, protocol review for operational feasibility and consistency, CRO/vendor feasibility, request for proposal and bid defense process, country/site feasibility, tracking site selection, activation, and patient recruitment. The Clinical Trial Manager will also focus on the management of project timelines, relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), EDC and IXRS set up and development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines).

Essential Responsibilities

• Clinical operations leader and main point of contact with counterpart at outside vendor, CRO and/or trial sites; daily review and identification of potential issues or problems and communicates/escalates to project team.
• Assist in the critical development and review of key study documents (e.g. Protocols, ICF, study plans eCRF, etc.).
• Develop, maintain and promote effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel.
• Participate in Clinical Operations meetings as assigned.
• Lead reviews of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings, and figures.
• Work with junior CTM for oversight of in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues.
• Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and laisses with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
• Track patient and recruitment status using applicable spreadsheets and web portal tools.
• Assist in yearly IND updates including IBs and DSUR.

Requirements

• A minimum of a Bachelor’s degree or equivalent is required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• A minimum of ten years clinical operations experience
• A minimum of three years of experience leading clinical trials from start-up to database lock
• Experience with all three parts of leading a global Phase 2 and/or Phase 3 clinical trial: start up, treatment phase and database lock.
• Experience in start up and oversight of central lab, including depth specification review.
• Knowledge of sample collect and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests.
• Experience with data privacy and GDPR guidelines.
• Experience with the independent management and oversight of CROs/vendors required.
• Experience with double blind/placebo controlled studies required.
• Experience within a small biotech organization and flexibility to pivot quickly and think outside the box.
• Excellent attention to detail, accuracy in work and possesses strong analytical skills.
• Must think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems.
• Comprehensive knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials