Overview
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. 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.
The Clinical Trial Manager or Senior Clinical Trial Manager assists in the planning, implementation, and management of clinical studies from concept to completion. The position requires knowledge of clinical trial processes and prior experience in many aspects of trial execution from study start-up to study close-out, including assisting in the management of clinical vendors/CROs and assisting in the oversight of resources, budgets, contracts, and timelines.
Essential Duties and Responsibilities:
- Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements.
- Recruit global study sites and foster relationships with study investigators.
- Participate in the process of site and vendor selection, qualification, and activation.
- Develop Requests-for-Proposals and assist in vendor selection efforts.
- Assist in review and negotiation of vendor contracts and study site clinical trial agreements.
- Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
- Monitor the progress of trials, including enrollment and clinical trial material inventory.
- Review monitoring visit reports for completeness and adherence to the annotations.
- Assist in packaging/labeling/distribution of clinical trial material.
- Monitor and track biological samples for applicable analyses.
- Provide progress updates to management and during program team meetings.
- Assist in departmental budgeting, including accruals and projections.
- Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents.
- Assist in development of Clinical SOPs.
- Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports.
- Assist in electronic case report form design and development.
- Assist in IRT design and development.
- Participate in data cleaning activities and developing appropriate data outputs.
- Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research).
- Provide leadership and mentoring of other Clinical team members.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Required Education, Experience and Attributes:
- Preferred undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences).
- For Clinical Trial Manager, at least 5 years of relevant experience in oncology 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). For Senior Clinical Trial Manager, at least 7 years of relevant experience required.
- Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities.
- Experience with managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
- Ability to work well with global, multi-disciplinary teams.
- Experience in practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
- Experience with electronic data capture and data management software.
- Experience in the management of Clinical Research Associates.
- Excellent oral and written communication skills.
- Experience with reviewing monitoring trip reports
- Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment.
- Must be organized and be able to communicate effectively.
- Must be a self-starter.
- Strong learning orientation, curiosity, and commitment to science and patients.
