Erasca
Healthcare
AssociateClinicalTrialManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Associate Clinical Trial Manager at Erasca. Skills: Clinical trial management, eTMF management, CTMS management, Regulatory compliance. Assist in implementation of clinical research projects. Provide support for project teams”
Industry & Context.
Troubleshoot issues; Resolve issues
What They're Looking For.
Must Have
1-2 years of clinical operations experience, 1-2 years TMF/document management experience, 1-2 years clinical trial support experience, Experience with eTMF systems, Practical knowledge of ICH-GCP, Knowledge of US regulations, Knowledge of ex-US regulations, Ability to work with global teams, Ability to work with multi-disciplinary teams, Organized, Excellent oral communication skills, Excellent written communication skills, Learning orientation, Curiosity, Commitment to science, Commitment to patients
Nice to Have
Undergraduate degree in Biological Sciences, Undergraduate degree in allied health sciences, Experience with CTMS systems, Experience managing study vendors, Experience with CRO vendors, Experience with IRT/IXRS vendors, Experience with central laboratories vendors, Experience with eTMF/CTMS vendors
What You'll Do.
Assist in implementation of clinical research projects
Provide support for project teams
Assist in managing clinical vendors
Assist in managing CROs
Assist in oversight of resources
Assist in oversight of budgets
Assist in oversight of contracts
Assist in oversight of timelines
Manage creation of Trial Master File documents
Manage organization of Trial Master File documents
Manage maintenance of Trial Master File documents
Manage quality of Trial Master File documents
Maintain Clinical Trial Master System platform
Support Clinical Trial Master System platform
Manage global oncology clinical trials
Assist in managing global oncology clinical trials
Ensure studies comply with protocol
Ensure studies comply with ICH GCP
Ensure studies comply with local regulations
Support key study-related activities
Support study-related deliverables
Support implementation of training programs
Maintain study status updates
Provide progress updates to project teams
Present plan of action for issue resolution
Maintain eTMF platform
Support eTMF platform
Maintain CTMS platform
Support CTMS platform
Manage eTMF/CTMS access
Monitor eTMF/CTMS system performance
Troubleshoot eTMF/CTMS issues
Coordinate resolutions with vendor
Coordinate resolutions with study team
Support eTMF/CTMS system upgrades
Support eTMF/CTMS system patches
Support eTMF/CTMS system testing
Support eTMF/CTMS system validation
Maintain TMF structure
File documents into eTMF
Classify documents into eTMF
Index documents into eTMF
Perform ongoing review of trial TMFs
Assure quality of TMFs
Assure compliance of TMFs
Track missing documents
Triage missing documents
Resolve missing documents
Track nonconformant documents
Triage nonconformant documents
Resolve nonconformant documents
Collaborate to obtain required documents
Ensure timely filing of documents
Prepare for regulatory inspections
Prepare for sponsor inspections
Prepare for regulatory audits
Prepare for sponsor audits
Conduct monitoring visits
Perform duties in keeping with core values
Perform duties in keeping with policies
Perform duties in keeping with regulations
How You'll Work.
Team & Collaboration
Global, multi-disciplinary teams
Communication Scope
Oral communication; Written communication
Process & Methodology
Clinical trial management, Project management
Full Job Description
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 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 creation, organization, maintenance, and quality of Trial Master File documents and maintain and support the Clinical Trial Master System (CTMS) platform. 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 pr
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