Associate eCOA Manager

Worldwide Clinical Trials•Carolina, NC

1d•Remote

About The Position

The Associate eCOA Manager oversees key electronic clinical outcome assessment (eCOA) vendor deliverables, timelines, risks, budgets, and communications across assigned clinical studies. The role connects eCOA vendors, sponsors, and Worldwide study teams to help ensure systems and related activities meet study requirements throughout the clinical trial lifecycle. Responsibilities span project oversight, study design review, user acceptance testing, change management, data-transfer requirements, and issue resolution. The position is part of the Clinical Systems Department, which works across clinical technologies and offers opportunities for mentorship, training, and internal growth. This is a remote role open to candidates based in the United States. The person will collaborate with global teams across multiple time zones.

Requirements

A degree in a relevant discipline or equivalent experience.
At least 1 year of experience working with eCOA and clinical trials.
At least 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) and familiarity with eCOA topics, including eCOA designs and scales.
Strong project and time-management skills, including the ability to prioritize multiple projects and make effective decisions in a fast-paced, dynamic environment.
Effective client-facing and stakeholder communication skills, including the ability to escalate risks and project issues clearly and promptly.
Strong attention to detail, sound independent judgment, and a proactive, organized, and collaborative approach.
Adaptability and problem-solving skills, including the ability to work with new technologies, concepts, and processes and identify opportunities for improvement.
Proficiency in written and spoken English for day-to-day business and effective stakeholder collaboration.

Responsibilities

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