Clinical Trial Manager/sr. CTM

Clinical Trial Manager/Senior Clinical Trial Manager

As a key member of the Clinical Operations teams, the (Senior)/Clinical Trial Manager will play a key contributor role in the strategic implementation and execution of clinical trial(s) from study start up to close-out. The incumbent will have responsibilities for the management and oversight of CRO’s, study vendors and clinical trial sites, and will partner key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOP’s.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Support the clinical operations team in the successful execution of clinical trials from protocol concept to clinical study report

• Prepare and maintain study related files

• Organize study and departmental meetings, take minutes, and ensure all study documentation is appropriately archived

• Coordinate clinical trial equipment and supplies

• Coordinate cross‐functional project related activities (e.g., Clinical Data Review Meetings)

• Ensure clinical team compliance with all required study specific training

• Perform TMF reviews to ensure completeness

• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections

• Assist with budget management

• Support the day‐to‐day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements

• Activities may include tracking of appropriate subject and site activity/metrics, performing quality check activities across components of the clinical study, etc

• Proactively identify and escalate issues that arise related to support functional deliverables

• Assist in study set‐up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT, ), and regulatory submissions, study operational manuals, training manuals, investigator document review, various study plans (i.e., visit logs, drug inventory, monitoring plans, etc.), and other study‐related requests

• Collaborate with CRO on the timely collection and archiving of TMF documents for assigned studies/programs

• Coordinate with regulatory affairs on the ongoing submission of essential documents to regulatory authorities

• Assist in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensure that all documents are available for the CSR

• Effectively communicate with study team members and work closely with Clinical Trial Managers and/or Asset Leads

• May participate in process improvement and quality‐related initiatives associated with study execution and deliverables.

• Work to ensure the achievement of study timelines including FPI, enrollment targets, site activation, and data cleaning goals.

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 pharma/biotech experience will be considered.
• Experience in the conduct of pre-NDA (phase I to III) oncology clinical trials, to include trial set-up, monitoring, and close out
• Strong working knowledge of ICH/GCP regulations
• Experience with electronic systems such as eTMF, CTMS, EDC, etc
• Ability to work independently with minimal direction/oversight and within a team structure
• Ability to think critically in fast‐paced environment with a keen sense of urgency and a demonstrated ability to problem solve
• Must have excellent interpersonal, written, verbal communication, computer, organization and administrative skills
• Proficiency in MS Office applications and comfortability with technology
• Minimal travel required (5 to 10%)

Compensation:

In addition to a competitive base salary ranging from $125,000 to $145,000 for a Clinical Trial Manager and $145,000 to $170,000 for a Senior Clinical Trial Manager, we offer stock options, 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, internal equity and work location.

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 10% (CTM)-15% (Sr. CTM)

Work Location:

• Onsite - 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.