Clinical Trial Manager – Senior
Job 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