Associate eCOA Manager

🔥 2 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $71.5k - $142.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Manage eCOA project activities from system maintenance through decommissioning • Keep deliverables and timelines on track and aligned with Worldwide SOPs • Partner with eCOA vendors, sponsors, and internal study teams to identify trends, address requirements, manage risks, and resolve project issues • Coordinate project communications, including status reports, meeting agendas, minutes, project calls, and stakeholder updates • Oversee eCOA study design activities • Review post-go-live scope changes and approve User Requirements Specifications (URS) as required • Review User Acceptance Test plans and oversee testing activities • Facilitate sponsor completion of system user acceptance testing • Manage vendor work orders, budgets, financial reviews, and Change Orders • Prepare and review site, support, and helpdesk materials • Perform quality-control checks on manual database edits and other activities as required • Facilitate collaboration between eCOA processes and Data Management data-transfer requirements • Provide eCOA input for protocol amendments

🎯 Requirements

• A degree in a relevant discipline or equivalent experience • Minimum of 1 year of experience working with eCOA and clinical trials • Minimum of 1 year of project management experience • Knowledge of Phase I–IV clinical research operations, gained within a Contract Research Organization (CRO) or pharmaceutical environment • Knowledge of the Software Development Life Cycle (SDLC) • Familiarity with eCOA topics, including eCOA designs and scales • Strong project and time-management skills • Effective client-facing and stakeholder communication skills • Strong attention to detail and sound independent judgment • Proactive, organized, and collaborative approach • Adaptability and problem-solving skills • Proficiency in written and spoken English • Equivalent experience may substitute for the relevant degree

🏖️ Benefits

• Competitive benefits package depending on location • Inclusive and equitable workplace • Mentorship, training, and internal growth opportunities

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