Clinical Trial Manager – Senior

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🏄 California – Remote

🏄 California – Remote

💵 $145k - $190k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Erasca, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $100M Post-IPO Equity on 2022-12

Biotechnology • Pharmaceuticals • Science

Erasca, Inc. is a clinical-stage precision oncology company committed to eradicating cancer by targeting one of cancer's most commonly mutated pathways, the RAS/MAPK pathway. The company is dedicated to developing a modality-agnostic portfolio of therapeutic programs designed to thoroughly shut down the RAS/MAPK pathway, which affects millions of lives globally each year. Erasca is advancing a robust pipeline with the potential to transform cancer treatment and improve the lives of patients suffering from various types of cancer. With a focus on groundbreaking science in oncology, Erasca aims to bring new hope to patients and lead the way in precision oncology innovations.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Paid Time Off • Holiday and Sick Leave • Medical, Dental and Vision Plans • Short- and Long-Term Disability • Basic and Voluntary Life/AD&D Coverage • Flexible Spending Accounts (FSA, HSA, and Commute) • Critical Illness and Accident Coverage • Pet Insurance • Employee Assistance Program • 401(k) Plan with Erasca contribution • Opportunity to participate in an Employee Stock Purchase Program