eCOA & RTSM Application Specialist

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

📋 Description

• Assist in the design, deployment, configuration, and management of eCOA solutions, such as ePRO, eConsent, and patient-centric electronic data capture tools.

• Provide support for Randomization and Trial Supply Management (RTSM) across international clinical studies.

• Serve as the subject matter expert for eCOA and RTSM during the start-up, maintenance, and closure of studies.

• Establish functional requirements and engage in solution design and configuration.

• Draft and uphold system specifications, user requirements, edit checks, notifications, and reporting criteria.

• Assist in the design of eCOA-related Case Report Forms (CRF).

• Develop User Acceptance Testing (UAT) scripts and coordinate or conduct system validation testing.

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

• Aid in CDISC-compliant data mapping and collaborate with Clinical Data Standards teams.

• Contribute to data-cleaning strategies and review plans such as Data Management Plans (DMPs) and edit-check specifications.

• Prepare training materials specific to studies and assist in the delivery of training.

• Lead or participate in meetings with internal teams, sponsors, and vendors concerning system setup, modifications, and issue management.

• Document system configurations and file eCOA and RTSM deliverables in the Trial Master File (TMF).

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

• Resolve 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 Standard Operating Procedures (SOPs), work instructions, process enhancements, templates, and eCOA/RTSM standards.

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

• Keep abreast of emerging eCOA and RTSM technologies, regulatory trends, and best practices.

• Support vendor evaluation, standardization, and relationship management when necessary.

• Advise cross-functional teams on eCOA and RTSM processes, timelines, and associated risks.

• Undertake additional responsibilities as assigned when qualified and sufficiently trained.

⛳️ Requirements

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

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

• Profound knowledge of eCOA systems and patient-reported outcomes (ePRO).

• Strong understanding of clinical trial processes and data management principles; familiarity with CDISC is an advantage.

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

• Ability to collaborate effectively in cross-functional environments and manage various priorities.

• Analytical mindset complemented by strong problem-solving capabilities.

• Exceptional written and verbal communication skills.

• Experience with global trials and knowledge of regulatory requirements (FDA, EMA, GDPR, HIPAA).

• Commitment to quality and data integrity.

• A technical curiosity and a digital mindset.

• Awareness of problem-solving and escalation processes.

• Strong skills in stakeholder communication and collaboration.

• Excellent organizational skills, accountability, and independence.

• Familiarity with good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in Argentina.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Ongoing opportunities for learning and development.

• Attractive prospects for advancement.

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