Senior EDI Analyst
Trilogy Federal
eCOA Analyst
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support all COAs (Clinician Reported Outcomes, Patient Reported Outcomes, Observer Reported Outcomes, & Performance Outcomes)
- Assist in the implementation of eCOA and paper-based COA during clinical trial execution.
- Act as a core team member for eCOA development, including device testing, deployment, and ongoing maintenance.
- Provide expertise on PRO/COA scientific principles to ensure consistency across Therapeutic Areas (TAs) and seamless integration among all eCOA vendors.
- Ensure the ongoing quality, precision, and integrity of COA instruments throughout the duration of clinical trials.
- Contribute to vendor selection processes by providing insightful input.
- Participate in specification meetings to support the design of ePRO application and monitoring reports.
- Review and approve ePRO specifications, screens, and prototypes—escalating concerns to the PRO lead when necessary.
- Develop and execute the PRO Completion Guidelines
- Key member of User Acceptance Testing (UAT), executing assigned cases, documenting issues, and collaborating with cross-functional partners for resolution.
- Share best practices and lessons learned across studies, TAs, and teams to foster continuous improvement.
- Contribute to documentation that enhances COA processes, such as training materials and responsibility matrices.
- Monitor compliance metrics that impact PRO/COA quality.
- Stay informed on the latest scientific and industry best practices related to PRO/COA.
Requirements
- An undergraduate degree from an accredited institution or international equivalent required
- Read, write and speak English
- Four plus years of experience in CRO or healthcare related industry
- Proficient in Microsoft Office
- Working knowledge of Patient Focused Drug Development (PFDD) and 2009 PRO FDA Guidance and other relevant guidance and best practices is preferred.
- Strong interpersonal skills and demonstrated ability to work effectively as a member of cross-functional teams is required.
- Expertise working with eCOA/COA/ePRO
- Strong analytical skills with a keen eye for detail
- Excellent listening, verbal, and written communication skills.
- Ability to work independently and to involve management when needed.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eCOACOAePROUser Acceptance Testinganalytical skillsdevice testingspecification designPRO Completion Guidelinesdocumentationcompliance metrics
Soft skills
interpersonal skillscross-functional collaborationcommunication skillsindependenceattention to detailcontinuous improvementproblem-solvingteamworklistening skillsinput contribution
