eCOA & RTSM Application Specialist

Innovaderm Research Inc.

. Support the design, deployment, configuration, and oversight of eCOA solutions, including ePRO, eConsent, and other patient-centric electronic data capture tools, and RTSM across global clinical studies.

Posted 11/11/2026full-timeRemote • South AfricaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in eCOA and RTSM solutions, including system configuration, validation, and compliance with regulatory standards. Strong analytical and problem-solving skills are essential for managing clinical trial processes and ensuring data integrity.

Highest-signal resume keywords

ECOA System ExpertiseClinical Trial ProcessesSystem Configuration and ValidationUAT and Edit ChecksRegulatory Compliance (FDA, EMA)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ECOA SolutionsEPROEDCIRTCDISC KnowledgeData Management PrinciplesSystem Validation TestingUser Acceptance Testing (UAT)Data Cleaning StrategiesClinical Data Standards

Soft Skills

Analytical MindsetProblem-Solving SkillsExcellent Communication SkillsCollaborationOrganization

Tools & Technologies

EClinical SolutionsPatient-Centric Electronic Data Capture ToolsTrial Master File (TMF)SOPsWork Instructions

Industry Keywords

CROPharmaHealth TechnologyICH-GCPGDPRHIPAAGood Clinical PracticesHealth Canada Regulations

About the role

Key responsibilities & impact

Support the design, deployment, configuration, and oversight of eCOA solutions, including ePRO, eConsent, and other patient-centric electronic data capture tools, and RTSM across global clinical studies.
Act as an eCOA and RTSM subject matter expert during study start-up, maintenance, and close-out.
Define functional requirements and participate in solution design and configuration.
Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements.
Assist with eCOA-related Case Report Form (CRF) design.
Create User Acceptance Testing (UAT) 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 data cleaning strategies and review data management plans and edit check specifications.
Prepare study-specific training materials and support training delivery.
Lead or participate in internal and sponsor meetings regarding system setup, changes, and issue management.
Document system configuration and file eCOA and RTSM deliverables in 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 compliance 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 eCOA and RTSM processes, timelines, and risks.
May be assigned other responsibilities when appropriately experienced, qualified, and/or trained.

Requirements

What you’ll need

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.
Must be legally authorized to work in South Africa.

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Recruitment and selection accommodations for applicants with disabilities, upon request