Associate Clinical Trial Manager

Role Overview

• Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
• Support key study-related activities and deliverables.
• Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-related documents.
• Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
• Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues).
• Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows.
• Manage user accounts, permissions, roles and eTMF/CTMS access.
• Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members.
• Support eTMF/CTMS system upgrades, patches, testing, and validation activities.
• Maintain TMF structure and index according to ICH-GCP and Erasca SOPs.
• File, classify, and index documents into the eTMF.
• Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP.
• Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure timely filing.
• Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions).
• May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Requirements

• Preference for undergraduate degree in Biological Sciences or 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 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).
• 1-2 years experience in TMF/document management or clinical trial support.
• Experience with eTMF systems (e.g. Trial Interactive eTMF, Veeva Vault).
• Experience with Clinical Trial Master Systems (CTMS) (e.g. Trial Interactive CTMS, Medidata CTMS) preferred.
• Demonstrated track record of successfully supporting multiple projects, trials, and priorities.
• Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) preferred.
• Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations.
• Ability to work well with global, multi-disciplinary teams.
• Must be a self-starter able to thrive in an entrepreneurial, fast paced, and dynamic work environment.
• Must be organized with excellent oral and written communication skills.
• Strong learning orientation, curiosity, and commitment to science and patients.

Tech Stack

• Google Cloud Platform
• Vault

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
• Opportunity to participate in an Employee Stock Purchase Program