Clinical Trial Manager/Senior Clinical Trial Manager

3 weeks ago

San Mateo, United States Sagimet Biosciences Full time

About Us:

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit .


The Role:

The Senior/Clinical Trial Manager will manage and lead the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables. The Senior/Clinical Trial Manager will have independent oversight of outsourced Clinical Studies including but not limited to: 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, management of project timelines, relevant study plans (e.g. monitoring, study operations, quality, communications, etc.),

experience with EDC and IXRS set up and development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines).


Key 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.
  • Lead all three parts of a global Phase 2 and/or Phase 3 clinical trial: start up, treatment phase, and database lock.
  • Start up and oversight of central lab, including depth specification review.
  • May perform reconciliation and/or tracking of sample manifests using knowledge of sample collect and analysis process at the study level.
  • 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 liases with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
  • Experience with data privacy and GDPR guidelines.
  • Track patient and recruitment status using applicable spreadsheets and web portal tools.
  • Assist in yearly IND updates including IBs and DSUR.


Education and Experience 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 the independent management and oversight of CROs/vendors required.
  • Experience with double blind/placebo controlled studies required.
  • Experience with NASH studies preferred but not 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.


Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Sagimet through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with Sagimet prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Sagimet and Sagimet will not be responsible for any purported fees.

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