Clinical Trial Manager/Sr Clinical Trial Manager
About The Position
The Clinical Trial Manager or Senior Clinical Trial Manager assists in planning, implementing, and managing clinical studies from concept to completion. The role requires knowledge of clinical trial processes and experience across trial execution, from study start-up through close-out, including supporting management of clinical vendors and CROs and oversight of resources, budgets, contracts, and timelines. The position manages global Phase 1–3 oncology trials in accordance with the clinical development plan, ICH-GCP, and applicable FDA and other regulatory agency requirements. It also supports study documentation, vendor and site management, trial materials and data activities, budgeting, and collaboration across Erasca departments. The role provides leadership and mentoring to other Clinical team members. Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. Its programs target the RAS/MAPK pathway, and its mission is to “erase cancer.”
Requirements
- At least 5 years of relevant oncology clinical operations experience in a pharmaceutical company or CRO for the Clinical Trial Manager role, or at least 7 years for the Senior Clinical Trial Manager role.
- Relevant experience must include trial set-up, monitoring, and close-out of US and non-US trials across pre-NDA clinical research Phases 1–3.
- Demonstrated excellence in trial management, including a track record of successfully managing multiple projects, trials, and priorities.
- Experience managing study vendors, such as CROs, IRT providers, laboratories, and core ECG/imaging vendors.
- Ability to work effectively with global, multidisciplinary teams.
- Practical knowledge and experience implementing 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, able to communicate effectively, and self-starting.
- Strong learning orientation, curiosity, and commitment to science and patients.
Nice To Haves
- Undergraduate degree in life sciences or a health profession, such as pharmacy, medicine, nursing, or another allied health science.
Responsibilities
- Manage global Phase 1–3 oncology clinical trials in accordance with the clinical development plan, ICH-GCP, and FDA and 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 with vendor selection.
- Assist with review and negotiation of vendor contracts and study site clinical trial agreements.
- Manage study vendors, including CROs, IRT providers, laboratories, and core ECG/imaging vendors.
- Monitor trial progress, including 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 during program team meetings.
- Assist with departmental budgeting, including accruals and projections.
- Assist with development of protocols, consent forms, IRB/EC materials, and other trial documents.
- Assist with development of Clinical SOPs.
- Prepare, review, or approve study materials, including CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports.
- Assist with electronic case report form design and development.
- Assist with IRT design and development.
- Participate in data cleaning activities and development of appropriate data outputs.
- Understand and help fulfill the needs of other Erasca departments, such as Finance and Research.
- Provide leadership and mentoring to other Clinical team members.
- Perform duties in accordance with the Company’s core values, policies, and applicable regulations.
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
- Employee Stock Purchase Program
- Annual bonus eligibility
- Equity grant at hire and annually in the form of an option to purchase stock in the future for a specified price
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
