Sr. Clinical Trial Manager/Clinical Trial Manager
About Sagimet Biosciences:
Sagimet is a clinical-stage pharmaceutical company developing FASN inhibitors to treat non-alcoholic steatohepatitis (NASH) and various cancers. Our expertise in FASN enables us to break new ground in targeting dysfunctional metabolic pathways. Our lead program is in Phase 2 development. This scientist will join a successful team and contribute to development of our FASN inhibitors in NASH and in oncology.
- 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. Oversight of outsourced Clinical Studies; including but not limited to, development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines, edit check specifications, database build, query resolution and database cleaning), relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines
- Manage vendor selection process from request for proposal through bid defense and selection.
- Ensures operational feasibility and tactical implementation of clinical development plans and scenarios, including time, budget, and resource requirements.
- Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
- Work with clinical operations staff to achieve the established corporate goals within the expected time frames.
- 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
- Develops, maintains and promotes, effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel
- Participates in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements
- Prepare and maintain 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.
- 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
- Performs in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues
- Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
- Assist in the critical development and review of key study documents (eg, Protocol, ICF, study plans, eCRF etc.)
- Some travel may be required.
- Experience with the management and oversight of CROs/vendors preferred.
- Experience within a small biotech organization and flexibility to pivot quickly and think outside the box
- Excellent attention to detail, accuracy in work and candidate 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
Education / Experience:
- Bachelor’s degree or equivalent is required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- A minimum of 5 years clinical operations experience
- A minimum of two years of experience leading clinical trials from start-up to database lock
Sagimet Biosciences is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Please send your resume along with a brief introduction to:
Executive Director, Clinical Operations