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This role ensures that digital platforms for patient-reported outcomes (PROs), electronic clinical outcome assessments (eCOA), and other trial technologies are deployed effectively, compliant with regulatory standards, and aligned with study protocols. The ideal candidate has deep expertise in clinical research operations, regulatory frameworks, and digital health technologies used in drug and device development.
Job Responsibility:
Manage the design, configuration, and deployment of in-house eCOA and PRO systems across global clinical trials
Collaborate with clinical operations, data management, biostatistics, and regulatory affairs to ensure technology solutions meet protocol requirements
Responsible for developing mockups, writing software requirements, and interfacing directly with development teams
Communicate status, issues, barriers, metrics, reports, and any other required/requested information to stakeholders as appropriate in a timely manner
Work effectively in a changing, high impact, fast paced, environment with challenging deadlines and resource constraints managing multiple projects with tight deadlines
Create documentation for the project and/or individual aspects of the project as needed
Support postmortem reviews and improvement initiatives
Requirements:
Bachelor’s degree or equivalent education and/or experience
At least 3 years’ related experience in system development, lifecycle methodology, and other disciplines relevant to eCOA system design, such as statistics, economics and validation of clinical data gathering instruments
Strong knowledge of clinical outcome assessments (COAs), eCOA platforms, and digital health technologies
Familiarity with regulatory requirements for clinical trials and patient data
Proficiency in Microsoft operating systems
Strong written and verbal communication skills
Nice to have:
Knowledgeable of the software development life cycle
PMP Certification
What we offer:
paid days off
medical, dental, and vision insurance
may be eligible for a discretionary bonus
401(k) plan with employer match (currently set at 50%)