Clinical Trial Manager/Sr. CTM
Janux Therapeutics
6 hours ago
Remote friendly (San Diego County, CA)
United States
$134,000 - $153,000 USD yearly
Clinical Research and Development
Responsibilities:
- Lead execution of clinical trials from protocol concept through clinical study reports for complex oncology programs.
- Ensure inspection readiness by maintaining comprehensive study documentation and files.
- Organize and lead study/departmental meetings, including minute-taking and document archiving.
- Coordinate clinical trial equipment/supplies and cross-functional project activities (e.g., Clinical Data Review Meetings).
- Ensure team compliance with study-specific training and perform TMF reviews for completeness.
- Support clinical sites with audit and inspection preparation.
- Assist with budget management and daily clinical operations in adherence to SOPs, ICH/GCP, and regulatory requirements.
- Monitor subject and site activity/metrics; perform quality checks across study components.
- Proactively identify, troubleshoot, and escalate issues impacting deliverables.
- Contribute to study set-up (protocol/synopsis development, informed consent forms, CTMS/IRT configuration, regulatory submissions, operational documentation).
- Collaborate with CROs to ensure timely collection and archiving of TMF documents.
- Partner with regulatory affairs on essential document submissions.
- Support study close-out (TMF and drug reconciliation and CSR readiness).
- Foster communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads.
- Participate in process improvement and quality initiatives.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree; at least 5 years of hands-on clinical trial experience in pharma/biotech (CRO and/or sponsor-side experience considered).
- Demonstrated experience in oncology trials (set-up, monitoring, close-out).
- Global clinical trial management experience (EU experience highly desirable).
- Strong working knowledge of ICH/GCP.
- Proficiency with eTMF, CTMS, EDC, and other electronic systems.
- Ability to work independently and in a collaborative team environment.
- Strong critical thinking, urgency, and proactive problem-solving.
- Excellent interpersonal, written, and verbal communication.
- Proficiency in MS Office and comfort with technology.
- Minimal travel (0–5%).
Benefits:
- Annual bonus program
- Incentive stock option plan
- 401k plan with flat non-elective employer contribution
- Comprehensive medical insurance (90–100% employer-paid premiums)
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO
- Generous holiday schedule (summer and winter shutdown)
- Relocation assistance
- Lead execution of clinical trials from protocol concept through clinical study reports for complex oncology programs.
- Ensure inspection readiness by maintaining comprehensive study documentation and files.
- Organize and lead study/departmental meetings, including minute-taking and document archiving.
- Coordinate clinical trial equipment/supplies and cross-functional project activities (e.g., Clinical Data Review Meetings).
- Ensure team compliance with study-specific training and perform TMF reviews for completeness.
- Support clinical sites with audit and inspection preparation.
- Assist with budget management and daily clinical operations in adherence to SOPs, ICH/GCP, and regulatory requirements.
- Monitor subject and site activity/metrics; perform quality checks across study components.
- Proactively identify, troubleshoot, and escalate issues impacting deliverables.
- Contribute to study set-up (protocol/synopsis development, informed consent forms, CTMS/IRT configuration, regulatory submissions, operational documentation).
- Collaborate with CROs to ensure timely collection and archiving of TMF documents.
- Partner with regulatory affairs on essential document submissions.
- Support study close-out (TMF and drug reconciliation and CSR readiness).
- Foster communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads.
- Participate in process improvement and quality initiatives.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree; at least 5 years of hands-on clinical trial experience in pharma/biotech (CRO and/or sponsor-side experience considered).
- Demonstrated experience in oncology trials (set-up, monitoring, close-out).
- Global clinical trial management experience (EU experience highly desirable).
- Strong working knowledge of ICH/GCP.
- Proficiency with eTMF, CTMS, EDC, and other electronic systems.
- Ability to work independently and in a collaborative team environment.
- Strong critical thinking, urgency, and proactive problem-solving.
- Excellent interpersonal, written, and verbal communication.
- Proficiency in MS Office and comfort with technology.
- Minimal travel (0–5%).
Benefits:
- Annual bonus program
- Incentive stock option plan
- 401k plan with flat non-elective employer contribution
- Comprehensive medical insurance (90–100% employer-paid premiums)
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO
- Generous holiday schedule (summer and winter shutdown)
- Relocation assistance