Project Management Specialist, Optimized Trials

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November 21

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Elligo Health Research

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Healthcare • Pharmaceuticals • Biotechnology

Elligo Health Research is a company that facilitates clinical trials by bridging the gap between research and healthcare. They provide essential tools and services such as patient recruitment, engagement, and innovative technologies, including their proprietary IntElligo® system. With access to a vast network of healthcare and research sites, Elligo supports sponsors, clinical trial sites, and patients in navigating the complex landscape of clinical research across a wide range of therapeutic areas.

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

💰 $135M Series E on 2021-09

📋 Description

• Serves as a liaison between multiple departments to ensure project tasks are tracked and/or completed. • Supports Elligo projects by coordinating collection and submission of all regulatory related documents. • Obtaining and reviewing required medical records, data entry, and other various project support tasks. • Performs set-up, maintenance and close out project files and study information. • Works within forecasted submission/approval timelines and ensures they are compiled with and tracks milestone progress in real time. • Prepares and completes the preparation of regulatory documents required for IRB/IBC approvals. • Oversees ongoing submissions, amendments, and periodic notifications required by central IRB. • Assists with coordination of team meetings, attends meetings, and prepares accurate meeting minutes and action items. • Records the status of milestones and key performance indicators. • Ensures all study documents are filed in eISF as required based on the appropriate guidelines.

🎯 Requirements

• BS/BA in Life Science or related discipline • Minimum of one (1) year clinical research experience (including Study Coordinator, CRO experience) or working in a healthcare setting. • Previous GCP training and certification is preferred. • Experience working with electronic medical records (EMRs); electronic health record system proficiency is preferred. • Data entry experience is preferred.

🏖️ Benefits

• Fully Remote Work