Clinical Trial Manager/Sr Clinical Trial Manager

The role

The Clinical Trial Manager or Senior Clinical Trial Manager assists in the planning, implementation, and management of clinical studies from concept to completion. This role involves managing global oncology trials and overseeing vendors, budgets, contracts, and timelines.

What you will do

• Manage global clinical trials (Phase 1-3) in oncology indications.
• 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 review and negotiation of vendor contracts and study site clinical trial agreements.
• Manage study vendors including CRO, IRT, laboratories, and core ECG/imaging.
• Monitor the progress of trials, including enrollment and clinical trial material inventory.
• Review monitoring visit reports for completeness and adherence to annotations.
• Assist in packaging, labeling, and distribution of clinical trial material.
• Monitor and track biological samples for applicable analyses.

Required qualifications

• 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
• For Senior Clinical Trial Manager, at least 7 years of relevant experience required.
• Demonstrated excellence in trial management skills with track record of 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.

Nice to have

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

Benefits

• Paid Time Off
• Holiday
• 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

About the company

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Their programs take novel approaches to shutting down the RAS/MAPK pathway.