The eCOA and RTSM Application Specialist is responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions—including ePRO, eConsent, and other patient-centric electronic data capture tools— and of Randomization and Trial Supply Management (RTSM) across global clinical studies.
This role collaborates with cross-functional teams, Sponsors, and external vendors to ensure that eCOA and RTSM systems are implemented in alignment with study protocols, regulatory expectations, and industry standards. The eCOA and RTSM Specialist acts as a subject matter expert throughout the study lifecycle to ensure reliable data collection, optimal user experience, and data integrity.
RESPONSIBILITIES
More specifically, the eCOA and RTSM Application Specialist must:
- Act as cCOA and RTSM subject matter expert during study start-up, maintenance, and close-out.
- Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions.
- Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements.
- Assist with the design of eCOA-related Case Report Forms (CRFs).
- Create User Acceptance Testing (UAT) test scripts and coordinate or perform system validation testing.
- Validate eCOA logic, rules, and study calculations against protocol requirements.
- Support CDISC-compliant data mapping and collaborate with Clinical Data Standards teams.
- Contribute to the development of data cleaning strategies and review relevant plans (e.g., DMP, edit check specifications).
- Prepare study-specific training materials (site guides, participant instructions, etc.) and support training delivery as needed.
- Lead or participate in internal and sponsor meetings related to system setup, changes, and issue management.
- Document system configuration and file eCOA and RTSM deliverables into the Trial Master File (TMF).
- Manage updates, amendments, and change requests throughout the study lifecycle.
- Troubleshoot issues, escalate risks, and ensure timely resolution with vendors and project teams
- Ensure eCOA and RTSM activities comply with ICH-GCP, FDA, EMA, and other relevant regulatory standards.
- Contribute to SOPs, work instructions, process improvement initiatives, templates, and eCOA and RTSM standards.
- Support continuous improvement, training, and knowledge sharing within Clinical Data Management.
- Stay current on emerging eCOA and RTSM technologies, regulatory trends, and best practices.
- Support vendor evaluation, standardization, and relationship management when applicable.
- Act as a resource for cross-functional teams regarding cCOA and RTSM processes, timelines, and risks.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
PROFILE
- Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or related field.
- 3–5 years of experience in eCOA, EDC, IRT, or eClinical solutions within a CRO, pharma, or health-technology environment.
- Strong knowledge of eCOA systems and patient-reported outcomes (ePRO).
- Solid understanding of clinical trial processes and data management principles (CDISC knowledge is an asset).
- Experience with system configuration, UAT, edit checks, and validation activities.
- Ability to collaborate in cross-functional settings and manage multiple priorities.
- Analytical mindset with strong problem-solving skills.
- Excellent written and verbal communication skills.
- Global trial experience and knowledge of regulatory expectations (FDA, EMA, GDPR, HIPAA).
- Attention to quality and data integrity
- Technical curiosity and digital mindset
- Problem solving and escalation awareness
- Stakeholder communication and collaboration
- Organization, accountability, and autonomy
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
