Currentjob openings

Position Summary:  

Reporting to a Director of Clinical Operations, 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.

Note that this position can be hybrid in San Diego or South San Francisco, or fully remote elsewhere in the US with travel to San Diego as needed.

Essential Duties and Responsibilities: 

• Manage or assist in the management of large global oncology clinical trials (Phase 1-3), 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, informed consent form, 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 TMF(s) 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 professions (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 pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3).
• 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.