Clinical Trial Manager – Senior

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee international clinical trials (Phase 1-3) in oncology, ensuring compliance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency standards.

• Identify and establish relationships with global study sites and principal investigators.

• Engage in the selection, qualification, and activation processes for sites and vendors.

• Create Requests-for-Proposals and support vendor selection activities.

• Aid in the review and negotiation of vendor contracts and clinical trial agreements with study sites.

• Supervise study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).

• Track trial progress, including participant enrollment and inventory of clinical trial materials.

• Evaluate monitoring visit reports for thoroughness and compliance with annotations.

• Assist in the packaging, labeling, and distribution of clinical trial materials.

• Oversee and monitor biological samples for relevant analyses.

• Provide updates on progress to management and during program team meetings.

• Support departmental budgeting, including accruals and forecasts.

• Contribute to the development of protocols, consent forms, IRB/EC materials, and additional trial documents.

• Assist in the creation of Clinical Standard Operating Procedures (SOPs).

• Prepare, review, and approve study documentation such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports.

• Aid in the design and development of electronic case report forms.

• Assist in the design and development of interactive response technology (IRT).

• Participate in data cleaning initiatives and the creation of suitable data outputs.

• Understand and address the needs of other Erasca departments (e.g., Finance, Research).

• Provide leadership and mentorship to other members of the Clinical team.

• Perform all responsibilities in alignment with the Company’s core values, policies, and applicable regulations.

⛳️ Requirements

• Preferred undergraduate degree in life sciences or related fields (pharmacy, medicine, nursing, or other allied health sciences).

• For Clinical Trial Manager, a minimum of 5 years of pertinent experience in oncology clinical operations within a pharmaceutical company or CRO, including trial set-up, monitoring, and close-out for US and international trials across all phases of pre-NDA clinical research (Phases 1-3).

• For Senior Clinical Trial Manager, at least 7 years of relevant experience is required.

• Proven excellence in trial management, with a history of successfully overseeing multiple projects, trials, and priorities.

• Experience in managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).

• Ability to collaborate effectively with global, multi-disciplinary teams.

• Knowledge of and practical experience implementing ICH-GCP guidelines and US and international regulations.

• Familiarity with electronic data capture and data management software.

• Experience in managing Clinical Research Associates.

• Exceptional oral and written communication abilities.

• Experience in reviewing monitoring trip reports.

• Must excel in an entrepreneurial, fast-paced, and dynamic work environment.

• Must be organized and possess effective communication skills.

• Must be a self-motivated individual.

• Strong inclination towards learning, curiosity, and a commitment to science and patient care.

🏝️ 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