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Janux Therapeutics · 2 days ago

Clinical Trial Manager

San Diego County, CA

Full-time

Onsite

Senior Level

$134K/yr - $153K/yr

5+ years exp

Janux Therapeutics is a mission-driven biotech company focused on oncology programs. The Clinical Trial Manager will oversee the execution of clinical trials, manage CROs and vendors, and ensure compliance with regulatory requirements while contributing to trial strategy and operational delivery.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

No H1B

Responsibilities

Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs

Ensure inspection readiness by maintaining comprehensive study documentation and files

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 audit and inspection preparation

Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements

Monitor subject and site activity/metrics and perform quality checks across study components

Proactively identify, troubleshoot, and escalate issues impacting 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

Partner with regulatory affairs on essential document submissions

Support study close-out activities including TMF and drug reconciliation and CSR readiness

Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads

Participate in process improvement and quality initiatives related to study execution

Other duties as deemed necessary

Qualification

Clinical trial managementOncology trials experienceICH/GCP regulationsETMFCTMSEDC proficiencyBudget managementCommunication skillsCritical thinking skillsTeam collaboration

Required

Bachelor's degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered

Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out

Global clinical trial management experience, especially in the EU, highly desirable

Strong working knowledge of ICH/GCP regulations

Proficiency with electronic systems such as eTMF, CTMS, EDC, etc

Ability to work independently 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%)