Associate eCOA Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee eCOA project activities from the maintenance phase through to decommissioning.

• Ensure that deliverables and timelines are maintained and in accordance with Worldwide SOPs.

• Collaborate with eCOA vendors, sponsors, and internal study teams to identify trends, fulfill requirements, manage risks, and address project challenges.

• Manage project communications, which include status reports, meeting agendas, minutes, project calls, and updates for stakeholders.

• Supervise eCOA study design processes.

• Evaluate post-go-live scope modifications and approve User Requirements Specifications (URS) as necessary.

• Assess User Acceptance Test plans and oversee the testing processes.

• Assist sponsors in completing system user acceptance testing.

• Administer vendor work orders, budgets, financial assessments, and Change Orders.

• Create and review materials for sites, support, and helpdesk services.

• Conduct quality control checks on manual database modifications and other required activities.

• Foster collaboration between eCOA processes and Data Management data-transfer needs.

• Provide eCOA insights for protocol amendments.

⛳️ Requirements

• A degree in a relevant field or equivalent experience.

• At least 1 year of experience with eCOA and clinical trials.

• Minimum of 1 year of project management experience.

• Understanding of Phase I–IV clinical research operations, preferably gained within a Contract Research Organization (CRO) or pharmaceutical setting.

• Familiarity with the Software Development Life Cycle (SDLC).

• Knowledge of eCOA topics, including eCOA designs and scales.

• Exceptional project and time-management abilities.

• Strong client-facing and stakeholder communication skills.

• Keen attention to detail and sound independent judgment.

• A proactive, organized, and collaborative mindset.

• Adaptability and problem-solving capabilities.

• Proficiency in both written and spoken English.

• Equivalent experience may substitute for the relevant degree.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Opportunities for mentorship, training, and internal growth.