eCOA & RTSM Application Specialist

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

📋 Description

• Provide support for the design, implementation, configuration, and management of eCOA solutions, such as ePRO and eConsent, along with RTSM across global clinical trials.

• Serve as an expert in eCOA and RTSM during the phases of study initiation, management, and conclusion.

• Establish functional requirements and engage in the design and configuration of solutions.

• Create and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements.

• Assist in designing eCOA-related Case Report Forms.

• Develop UAT test scripts and coordinate or conduct system validation testing.

• Validate eCOA logic, rules, and study calculations in alignment with protocol requirements.

• Support CDISC-compliant data mapping and work collaboratively with Clinical Data Standards teams.

• Contribute to data cleaning strategies and review data management plans and edit check specifications.

• Prepare study-specific training materials and assist in training delivery.

• Lead or participate in meetings regarding system setup, modifications, and issue management.

• Document system configurations and archive eCOA and RTSM deliverables in the Trial Master File.

• Oversee updates, amendments, and change requests throughout the study's lifecycle.

• Troubleshoot issues, escalate risks, and ensure prompt resolution with vendors and project teams.

• Ensure adherence to ICH-GCP, FDA, EMA, and other pertinent regulatory standards.

• Contribute to SOPs, work instructions, process enhancement initiatives, templates, and eCOA/RTSM standards.

• Promote ongoing improvement, training, and knowledge sharing within Clinical Data Management.

• Stay updated on new eCOA and RTSM technologies, regulatory developments, and best practices.

• Assist with vendor evaluation, standardization, and relationship management as required.

• Act as a resource for cross-functional teams regarding eCOA and RTSM processes, timelines, and risks.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or a related field.

• 3–5 years of experience with eCOA, EDC, IRT, or eClinical solutions within a CRO, pharmaceutical, or health technology setting.

• Strong understanding of eCOA systems and patient-reported outcomes (ePRO).

• Solid grasp of clinical trial processes and principles of data management.

• Knowledge of CDISC is an advantage.

• Experience with system configuration, UAT, edit checks, and validation tasks.

• Ability to work collaboratively in cross-functional environments and manage multiple priorities effectively.

• Analytical mindset complemented by strong problem-solving abilities.

• Excellent written and verbal communication skills.

• Experience in global trials and familiarity with regulatory expectations (FDA, EMA, GDPR, HIPAA).

• Strong attention to quality and data integrity.

• Technical curiosity paired with a digital mindset.

• Awareness of problem solving and escalation processes.

• Proficient in stakeholder communication and collaboration.

• Strong organizational skills, accountability, and ability to work independently.

• Knowledgeable about good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must have legal authorization to work in Canada.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Opportunities for ongoing learning and development.

• Attractive prospects for advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.