Clinical Trial Manager/Senior Clinical Trial Manager

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 (CTM) or 8 years (Sr. CTM) 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 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%).

In addition to a competitive base salary ranging from $140,000 to $154,000 for Clinical Trial Manager and $160,000 to $178,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus.  Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.
Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.