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Sr Clinical Trial Manager

San Diego, CA

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary: 

Reporting to a Director of Clinical Operations, the Sr Clinical Trial Manager will assist in the planning, implementation, and management of clinical studies from concept to completion.  The position requires knowledge of clinical trial processes and prior experience in many aspects of trial execution from study start-up to study close-out, including assisting in the management of clinical vendors/CROs and assisting in the oversight of resources, budgets, contracts, and timelines.

A Senior Clinical Trial Manager may independently lead one or more studies. 

Essential Duties and Responsibilities:

  • Manage and/or support 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 lead vendor selection efforts.
  • Assist in review and negotiation of vendor contracts and study site clinical trial agreements.
  • Setup and manage study vendors (e.g., CRO, IRT, laboratories, central ECG/imaging).
  • Able to independently review/edit vendor specification documents, as necessary.
  • Monitor the progress of trials, including enrollment and clinical trial material inventory.
  • 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, informed consent forms, IRB/EC materials, and other trial documents.
  • Prepare/review/approve study materials such as CRFs, 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.
  • Provide TMF oversight to ensure inspection readiness.
  • Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research).
  • Provide leadership and mentoring of other more junior Clin Ops team members.
  • Serve as support for a global study lead.
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education and Experience:

  • Undergraduate degree in life sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) preferred.
  • At least 7 years of relevant experience in 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).
  • Experience as a Clinical Research Associate or Clinical Research Coordinator required.
  • Extensive experience in Oncology, including clinical operations support for global clinical trials.
  • Experience in a pharmaceutical or biotech company required; experience in start up or small company highly preferred.
  • Demonstrated excellence in trial management skills, with track record of successfully managing multiple projects, trials, and priorities.
  • Experience managing study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging).
  • Experience with electronic data capture and data review.
  • Experience in the management of Clinical Research Associates.
  • Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment.
  • Must be organized and be able to communicate effectively.
  • Ability to work well with global, multi-disciplinary teams.
  • Excellent oral and written communication skills.
  • Strong learning orientation, curiosity, and commitment to science and patients.
  • Up to 25% travel.

The anticipated salary range for this position is $170,000 to $180,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. 

Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: 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, and the opportunity to participate in an Employee Stock Purchase Program. 

Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.