Clinical Trial Manager/Sr Clinical Trial Manager

Job not on LinkedIn

🕒 June 11

🏄 California – Remote

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💵 $145k - $190k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 33%

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Logo of Erasca, Inc.

Erasca, Inc.

51 - 200 employees

Founded 2020

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Post-IPO Equity on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Plan, implement, and manage clinical studies from concept to completion • Manage global Phase 1-3 oncology clinical trials 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 site and vendor selection, qualification, and activation • Develop Requests-for-Proposals and assist in vendor selection • Assist in reviewing and negotiating vendor contracts and study site clinical trial agreements • Manage study vendors, including CROs, IRT, laboratories, and core ECG/imaging providers • Monitor trial progress, enrollment, and clinical trial material inventory • Review monitoring visit reports for completeness and adherence to annotations • Assist with packaging, labeling, and distribution of clinical trial material • Monitor and track biological samples for applicable analyses • Provide progress updates to management and program team meetings • Assist with departmental budgeting, accruals, and projections • Assist in developing protocols, consent forms, IRB/EC materials, and other trial documents • Assist in developing Clinical SOPs • Prepare, review, and 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 and development of appropriate data outputs • Support the needs of other Erasca departments, including Finance and Research • Provide leadership and mentoring to other Clinical team members • Perform duties in accordance with company values, policies, and applicable regulations

🎯 Requirements

• Preferred undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) • Clinical Trial Manager: at least 5 years of relevant experience in oncology clinical operations in a 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) • Senior Clinical Trial Manager: at least 7 years of relevant experience required • Demonstrated excellence in trial management skills, with a track record of successfully managing multiple projects, trials, and priorities • Experience managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging) • Ability to work well with global, multi-disciplinary teams • Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations • Experience with electronic data capture and data management software • Experience managing Clinical Research Associates • Excellent oral and written communication skills • Experience reviewing monitoring trip reports • Ability to thrive in an entrepreneurial, fast-paced, and dynamic work environment • Organized and able to communicate effectively • Self-starter • Strong learning orientation, curiosity, and commitment to science and patients

🏖️ Benefits

• Annual bonus • Equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price • 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 • Employee Stock Purchase Program • Casual, collaborative, and fun work environment • Opportunity to contribute to Erasca’s mission to erase cancer

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