eCOA & RTSM Application Specialist

Innovaderm Research Inc.

. Support the design, deployment, configuration, and oversight of eCOA solutions, including ePRO, eConsent, and patient-centric electronic data capture tools .

Posted 11/11/2026full-timeRemote • ArgentinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in eCOA and RTSM solutions, including system configuration, validation, and compliance with regulatory standards such as ICH-GCP and FDA. Possesses strong analytical and problem-solving skills, with the ability to collaborate effectively in cross-functional teams and manage multiple priorities.

Highest-signal resume keywords

ECOA System ExpertiseClinical Trial ProcessesSystem Configuration and ValidationRegulatory Compliance KnowledgeUser Acceptance Testing (UAT)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ECOA SolutionsEPRORandomization and Trial Supply Management (RTSM)Case Report Form (CRF) DesignCDISC Data MappingSystem Specifications DraftingEdit ChecksData Management PrinciplesValidation ActivitiesEmerging eCOA Technologies

Soft Skills

Analytical MindsetProblem-Solving SkillsExcellent Communication SkillsAttention to QualityCollaboration

Tools & Technologies

Electronic Data Capture (EDC)Interactive Response Technology (IRT)Trial Master File (TMF)Data Management Plans (DMPs)Training Materials Development

Industry Keywords

Clinical Research Organization (CRO)Health TechnologyGood Clinical Practices (GCP)FDA RegulationsEMA RegulationsGDPR ComplianceHealth Canada Guidelines

About the role

Key responsibilities & impact

Support the design, deployment, configuration, and oversight of eCOA solutions, including ePRO, eConsent, and patient-centric electronic data capture tools
Support Randomization and Trial Supply Management (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 plans such as DMPs and edit-check specifications
Prepare study-specific training materials and support training delivery
Lead or participate in meetings with internal teams, sponsors, and vendors 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 improvements, templates, and eCOA/RTSM standards
Support continuous improvement, training, and knowledge sharing within Clinical Data Management
Monitor emerging eCOA and RTSM technologies, regulatory trends, and best practices
Support vendor evaluation, standardization, and relationship management when applicable
Advise cross-functional teams on eCOA and RTSM processes, timelines, and risks
Perform other assigned responsibilities when qualified and adequately 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 FDA regulations/guidelines
Must be legally authorized to work in Argentina

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