ePRO Manager - Remote

Overview

Are you a seasoned ePRO expert looking to take ownership of a specialized function in a growing global organization? Alimentiv is seeking an experienced ePRO Manager to lead the design, implementation, and oversight of electronic Patient Reported Outcomes (ePRO) systems in clinical trials.

In Short

• Lead all ePRO-related activities in study startup and maintenance.
• Serve as the subject matter expert (SME) for internal and external stakeholders.
• Define and document system requirements and study-specific calculations.
• Support CDISC-compliant data mapping and regulatory submission documentation.
• Develop training materials for site staff and participants.
• Act as the main point of contact for ePRO issues throughout the trial lifecycle.
• Participate in bid defense meetings and client discussions.
• Contribute to the development and standardization of ePRO processes.
• Collaborate with cross-functional teams including Clinical Data Standards and Regulatory Affairs.
• Support business development by consulting on new ePRO opportunities.

Requirements

• 4–6 years of hands-on experience in ePRO implementation in clinical trials.
• Deep understanding of the ePRO lifecycle.
• Familiarity with FDA, EMA, ICH-GCP, and other regulatory frameworks.
• Prior work with external ePRO vendors.
• Experience presenting at bid defenses and working with clients.
• Bachelor’s degree in a scientific or technical field (or equivalent experience).

Benefits

• Opportunity to evolve into a leadership role.
• Work in a growing global organization.
• Collaborate with a Full-Service Data Management team.
• Engage in innovative and operational excellence initiatives.