Position: Associate Clinical Trial Manager
Function: Clinical Operations
Company: Phanes Therapeutics, Inc.
Location: San Diego, CA
Phanes Therapeutics is an emerging leader in innovative discovery research and clinical development in oncology. The company received two IND clearances from the FDA in the first half of this year, one (PT199) for solid tumors and another (PT886) for pancreatic, GEJ and gastric cancers. A third program from the company (PT217) has just received orphan drug designation from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.
This position is in the clinical operations function located at our R&D site in San Diego, CA. The Associate Clinical Trial Manager will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires knowledge of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out, including assisting in the management of clinical vendors or CROs and assisting in the oversight of resources, budgets, contracts, and timelines.
- Manage or assist in the management of multicenter oncology clinical trials, ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
- Support key study-related activities and deliverables.
- Participate in site and vendor selection and qualification.
- Conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO, review trip reports, and implement training as needed to ensure compliance with the protocol and other study-related documents.
- Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
- Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues).
- Review and provide input on study documents (e.g., study protocol, ICF, CRFs, patient-facing materials, drug accountability forms, study manuals, monitoring plans, monitoring reports).
- Participate in data review and cleaning activities.
- Perform ongoing review of trial eTMF to assure quality and compliance with relevant SOPs and ICH-GCP.
- Perform all duties in keeping with the Company's core values, policies, and all applicable regulations.
Required Education and Experience:
- Undergraduate degree in Biological Sciences or other professional degree (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 5 years of relevant experience.
- At least 2 years of oncology experience in clinical operations in biotech/pharmaceutical company or CRO including trial set-up, monitoring, and close-out US and trials
- Demonstrated track record of successfully supporting multiple projects, trials, and priorities.
- Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories) preferred.
- Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
- Experience with electronic systems (e.g., eTMF, EDC, and other data management software).
- Ability to work well with global, multi-disciplinary teams.
- Must be able to thrive in an entrepreneurial, fast paced, and dynamic work environment.
- Must be organized with excellent oral and written communication skills.
- Strong learning orientation, curiosity, and passion for science and patients.