Clinical Trial Manager

September 23

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Orca

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Description

• Exciting opportunity to join Orca Bio's newly created early stage clinical team! • Assist with the day-to-day management of early stage clinical studies. • Ensure studies are delivered on time, within budget, and in compliance with the protocol. • Manage day-to-day activities of clinical vendors and in-house CRA team. • Provide study-specific training and leadership to clinical research staff. • Assist with monitoring overall CRA, site and vendor performance. • Identify potential study issues and optimize delivery of scoped services. • Leverage operational and therapeutic expertise to optimize trial design and execution. • Prepare and/or review study-related documents. • Track and manage subject recruitment across study sites. • Oversee study monitoring visits and review monitoring reports. • Mentor and develop in-house CRA team. • Monitor site performance and escalate issues. • Oversee ongoing protocol deviation tracking and reporting. • Follow international good clinical practice guidelines. • Provide support for site initiation and close out visits. • Assist with development and management of clinical budgets and contracts. • Collaborate with cross functional teams to ensure clean data.

Requirements

• BA/BS or equivalent with 5+ years of relevant clinical trial management experience. • Therapeutic experience in oncology/hematology and cell and gene therapy preferred. • Prior experience with early stage clinical trials at a small biotech/life science company preferred. • Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures. • Experience with Trial Master File management according to the DIA reference model. • Experience operating within various site EMR/EHR systems. • Experience using eTMF, EDC (IBM experience ideal), CTMS, and other vendors systems/portals.