Clinical Trial Manager

Location: South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week

Position Summary:

As TRexBio advances its first wholly owned asset into Phase 1 clinical trials, the company is seeking an experienced and dynamic Clinical Trial Manager, Clinical Operations to manage operational aspects of the company’s clinical trials.

Reporting directly to the Senior Director, Clinical Operations, the Clinical Trial Manager will partner with the cross-functional team to contribute to the execution of the clinical strategy of the company. The ideal candidate will bring strong experience in early-phase clinical trials, a collaborative management style, and a passion for advancing innovative therapies.

We are seeking a talented and highly motivated Clinical Trial Manager, Clinical Operations to join our Clinical Development team. This position offers an opportunity to work as part of a small, dynamic team to bring novel immunomodulatory drugs to clinic.

A passion for teamwork, a can-do attitude, integrity and transparency are key attributes for this position. Come join our team!

Key Responsibilities include but are not limited to:

• Supports the development of operational strategies including country and site feasibility and selection, CRO and vendor identification and selection
• Provides day-to-day management of study vendors to ensure projects are delivered according to contracted scope of work
• Provides operational input in the development and review of study documents (e.g., protocol, informed consent form, eCRF, site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)
• Reviews site visit reports, under the direction of the Clinical Trial Leadership.
• Initiates, reviews, and reconciles study files in the Trial Master File internal and with CROs
• Maintains accurate tracking and reporting of study metrics to support the conduct of the clinical trial(s) from start-up to close-out
• Manages and tracks study specific payments and manages any variances
• Coordinates investigational product release activities with CRO and clinical sites
• Ensures sites have all the appropriate non-clinical supplies (e.g. lab kits, study equipment) through close collaboration with the relevant cross-functional teams, vendors, and management of the supplies
• Collaborates with Data Management and Clinical Science to ensure quality data entry
• Contributes to the development and management of the trial timelines, budget, risk and quality plans
• Coordinates and leads meetings: vendor meetings, internal study team meetings, Investigator Meetings, etc.

Required Qualifications:

• BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred
• 5 years of experience in clinical operations, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
• Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines)
• Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role.
• Proven ability to proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments
• Ability to handle a moderate volume of highly complex tasks within a given timeline
• Requires strong organizational skills, attention to detail and ability to prioritize and problem solve
• Computer proficiency (Outlook, MS Word, Excel, and PowerPoint).
• Willingness to travel as necessary, consistent with project needs (domestic and international), up to 15%

Compensation: $120,000.00-$160,000.00, plus Discretionary Bonus.

Our Culture:

At TRexBio, you will have the opportunity to work with amazingly smart humans who strive to make the world a better place. In addition to our team-centric culture, we believe that your individual creativity will help us to be our best. Our staff happy hours, organized by our Culture Club, bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other’s achievement weekly and monthly at all company meetings that celebrate our work and our people.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.