Position Summary:
Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial Manager (aCTM) will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires knowledge of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out, including assisting in the management of clinical vendors or CROs and assisting in the oversight of resources, budgets, contracts, and timelines. The aCTM will also manage the oversight of the CRO’s TMF activities, including maintenance and quality control of Trial Master File documents.
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.
