Associate Clinical Trial Manager

Position Summary

The Associate Clinical Trial Manager (aCTM) will assist in the implementation and conduct of clinical research projects and provide support for project teams. Key responsibilities include managing or assisting in the management of large global oncology clinical trials, supporting key study-related activities and deliverables, overseeing vendor or CRO management, and maintaining the Trial Master File (TMF).

Essential Duties and Responsibilities

• 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 for clinical studies and operational workflows.
• Manage user accounts, permissions, roles and eTMF access.
• Maintain TMF structure and index according to ICH-GCP and Erasca SOPs.
• Review the CRO's work filing, classifying, and indexing documents into the eTMF.
• 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.

Required Education and Experience

• 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).
• 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.

Pay

The anticipated salary range for this position is $122,000 to $137,000. 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.

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