Associate Clinical Trial Manager

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

📋 Description

• Oversee or assist in the management of extensive global oncology clinical trials (Phase 1-3), ensuring compliance with the protocol, ICH GCP, and local regulatory standards.

• Facilitate key study-related activities and deliverables.

• Aid in the execution of training programs to ensure that relevant personnel receive the necessary training to comply with the protocol and other study-related documents.

• Monitor study progress and keep study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).

• Provide updates on progress to relevant project teams and present a plan of action for addressing issues (e.g., trial challenges, investigator/study coordinator feedback, monitoring concerns, patient enrollment difficulties).

• Maintain and support the eTMF for clinical studies and operational workflows.

• Manage user accounts, permissions, roles, and eTMF access.

• Maintain TMF structure and indexing in accordance with ICH-GCP and Erasca SOPs.

• Review the CRO’s work by filing, classifying, and indexing documents into the eTMF.

• Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to acquire the necessary documents and ensure timely filing.

• Prepare for and assist with regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions).

• May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) alongside contracted monitors/CRO.

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

⛳️ Requirements

• Preference for an undergraduate degree in Biological Sciences or related professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 1-2 years of relevant experience.

• At least 1-2 years of experience in clinical operations within a pharmaceutical company or CRO, encompassing trial setup, monitoring, and closeout of both US and non-US trials across all phases of pre-NDA clinical research (Phases 1-3).

• 1-2 years of experience in TMF/document management or clinical trial support.

• Familiarity with eTMF systems (e.g., Trial Interactive eTMF, Veeva Vault).

• Proven ability to successfully support multiple projects, trials, and priorities.

• Experience in managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) is preferred.

• Practical understanding and application of ICH-GCP guidelines and US and ex-US regulations.

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

• Must be a self-motivated individual who can excel in an entrepreneurial, fast-paced, and dynamic work environment.

• Must possess excellent organizational skills along with strong oral and written communication abilities.

• Strong orientation 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