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Associate Clinical Trial Manager or Clinical Trial Manager

San Diego, CA or remote

Erasca is a San Diego based biotechnology company focused on discovering and developing precision medicines for the benefit of patients with cancer. We are advancing multiple programs targeting biological drivers of cancer and are pursuing additional pipeline expansion opportunities through academic and biopharmaceutical collaborations. Our programs, currently focused on innovative discovery research, take novel approaches to shutting down certain oncogene drivers of solid tumor malignancies. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary: 

Reporting to an Associate Director or Director of Clinical Operations, the Associate Clinical Trial Manager or 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 positions will be filled at the Associate Clinical Trial Manager or Clinical Trial Manager level depending on the candidate's experience and the program or business need. 

Essential Duties and Responsibilities: 

  • 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. 
  • Assist in the management of 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. 
  • Assist with tracking study progress and maintaining 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 3 years of experience. Additional experience required for Clinical Trial Manager.
  • At least 2 years of relevant 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.

 

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

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