Septerna is a biotechnology company aiming to develop life-changing medicines for patients by becoming the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company seeks to solve unmet medical needs by developing novel therapeutics for GPCR-targeted small molecule programs.
Requirements
- Experience in Site Selection, Initiation, Interim and Close-Out visits.
- Ability to understand and discuss relevant clinical data.
- Broad knowledge and understanding of the design and critical review of clinical studies
- Previous CRA experience within biotech
- Priority given to proven experience in CRO oversight and sponsor-level responsibilities.
- Good knowledge of ICH GCP and FDA regulations
- Exercises independent judgment with problem-solving skills.
Responsibilities
- Lead and conduct sponsor oversight visits to ensure CRO monitoring activities meet study and regulatory standards.
- Review CRO monitoring reports, identify trends, and oversee timely resolution of issues.
- Track monitoring quality metrics and escalate significant compliance or quality concerns to Study Lead
- Contributes to the development of protocol, Informed Consent Form, Case Report Forms, and any additional key documents
- Maintain internal oversight trackers for site status, recruitment progress, data quality, and monitoring performance
- Track vendor deliverables and timelines, escalate issues, and coordinate resolution of site-level queries, study supplies, data entry, and related tasks
- Support vendor interactions by ensuring documentation is accurate, study systems are maintained, and site-facing needs are resolved in alignment with study timelines
Other
- Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
- Ability to work independently on multiple projects internally and with external vendors
- Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
- Experience in working across multiple regions and strong cross functional experience
- Ability to coordinate or manage multiple projects to meet project timelines/milestones.
