Clinical Trial Manager
Janux Therapeutics
San Diego, CA, USA
Posted on Jul 30, 2025
The Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trial(s) from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs.
As a key member of our Clinical Operations team, the incumbent will be at the forefront of shaping trial strategy, driving execution, and ensuring excellence in delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Support the successful execution of clinical trials from protocol concept to clinical study report in support of complex autoimmune programs.
- Prepare and maintain study-related files and documentation to ensure inspection readiness.
- Organize and lead study and 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 in preparation for audits and inspections.
- Assist with budget management and day-to-day clinical operations in compliance with SOPs, ICH/GCP, and regulatory requirements.
- Track subject and site activity/metrics and perform quality checks across study components.
- Proactively identify and escalate issues related to functional deliverables.
- Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation.
- Collaborate with CROs to ensure timely collection and archiving of TMF documents.
- Coordinate with regulatory affairs on essential document submissions.
- Support study close-out activities including TMF and drug reconciliation and CSR readiness.
- Communicate effectively with study team members and work closely with Clinical Trial Managers and/or Asset Leads.
- Participate in process improvement and quality initiatives related to study execution.
- Other duties as deemed necessary.
REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES
- Bachelor’s degree with at least 5 years of hands-on clinical trial experience, preferably within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered.
- Demonstrated experience in the conduct of first-in-human (FIH) and complex autoimmune clinical trials, including trial set-up, monitoring, and close-out.
- Strong working knowledge of ICH/GCP regulations.
- Proficiency with electronic systems such as eTMF, CTMS, EDC, etc.
- Ability to work independently with minimal oversight and thrive in a collaborative team environment.
- Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset.
- Excellent interpersonal, written, and verbal communication skills.
- Proficiency in MS Office and comfort with technology.
- Minimal travel required (0 to 5%).
Job Type: Full-time
Benefits:
· 401K
· Medical insurance
· Dental insurance
· Vision insurance
· Supplemental disability insurance plans
· Flexible schedule
· Life insurance
· Flexible vacation
· Sick time
· Incentive stock option plan
· Relocation assistance
Schedule:
· Monday to Friday
Work authorization:
· United States (Required)
Additional Compensation:
· Annual targeted bonus X%
Work Location:
· On site (San Diego, CA)
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies
The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.