Clinical Trial Manager/Senior Clinical Trial Manager
Janux Therapeutics
August 11, 2026
Remote friendly (San Diego County, CA)
United States
Clinical Research and Development
Responsibilities:
- Support execution of clinical trials from protocol concept through clinical study report for complex autoimmune programs.
- Prepare and maintain study documentation for inspection readiness; organize/lead study meetings and archive minutes.
- Coordinate trial equipment/supplies and cross-functional activities (e.g., clinical data review meetings).
- Ensure team compliance with study-specific training; perform TMF reviews for completeness.
- Support clinical sites for audits/inspections.
- Manage day-to-day clinical operations and budgets in compliance with SOPs, ICH/GCP, and regulatory requirements.
- Track subject/site activity metrics; perform quality checks and proactively escalate issues.
- Contribute to study set-up (protocol/synopsis, informed consent, CTMS/IRT configuration, regulatory submissions, operational documentation).
- Collaborate with CROs for timely TMF collection/archiving; coordinate essential submissions with Regulatory Affairs.
- Support close-out (TMF/drug reconciliation and CSR readiness).
Required Qualifications:
- Bachelor’s degree with 5+ years (CTM) or 8+ years (Sr. CTM) hands-on clinical trial experience (pharma/biotech preferred); CRO + sponsor-side experience considered.
- Experience in complex autoimmune trials (set-up, monitoring, close-out).
- Strong ICH/GCP knowledge.
- Proficiency with eTMF, CTMS, EDC (or similar).
- Independent, proactive, strong critical thinking; excellent written/verbal communication; MS Office.
- Minimal travel (0–5%).
Benefits (selected):
- Annual bonus; stock options/RSUs; ESPP; 401k employer contribution; medical (90–100% employer-paid premiums), dental/vision; HSA/FSA and supplemental insurance; unlimited PTO; relocation assistance.
- Support execution of clinical trials from protocol concept through clinical study report for complex autoimmune programs.
- Prepare and maintain study documentation for inspection readiness; organize/lead study meetings and archive minutes.
- Coordinate trial equipment/supplies and cross-functional activities (e.g., clinical data review meetings).
- Ensure team compliance with study-specific training; perform TMF reviews for completeness.
- Support clinical sites for audits/inspections.
- Manage day-to-day clinical operations and budgets in compliance with SOPs, ICH/GCP, and regulatory requirements.
- Track subject/site activity metrics; perform quality checks and proactively escalate issues.
- Contribute to study set-up (protocol/synopsis, informed consent, CTMS/IRT configuration, regulatory submissions, operational documentation).
- Collaborate with CROs for timely TMF collection/archiving; coordinate essential submissions with Regulatory Affairs.
- Support close-out (TMF/drug reconciliation and CSR readiness).
Required Qualifications:
- Bachelor’s degree with 5+ years (CTM) or 8+ years (Sr. CTM) hands-on clinical trial experience (pharma/biotech preferred); CRO + sponsor-side experience considered.
- Experience in complex autoimmune trials (set-up, monitoring, close-out).
- Strong ICH/GCP knowledge.
- Proficiency with eTMF, CTMS, EDC (or similar).
- Independent, proactive, strong critical thinking; excellent written/verbal communication; MS Office.
- Minimal travel (0–5%).
Benefits (selected):
- Annual bonus; stock options/RSUs; ESPP; 401k employer contribution; medical (90–100% employer-paid premiums), dental/vision; HSA/FSA and supplemental insurance; unlimited PTO; relocation assistance.