eCOA & RTSM Application Specialist

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

📋 Description

• Assist in the design, implementation, configuration, and management of eCOA solutions, such as ePRO, eConsent, and other patient-focused electronic data capture tools, as well as RTSM for global clinical trials.

• Serve as an eCOA and RTSM subject matter expert during the phases of study initiation, ongoing maintenance, and study closure.

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

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

• Aid in the design of Case Report Forms (CRF) related to eCOA.

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

• Verify eCOA logic, rules, and study calculations in accordance with protocol specifications.

• Support CDISC-compliant data mapping and collaborate effectively with Clinical Data Standards teams.

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

• Create training materials specific to the study and assist in training delivery.

• Lead or engage in internal and sponsor meetings related to system configuration, modifications, and issue resolution.

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

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

• Address 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 the development of SOPs, work instructions, process improvement initiatives, templates, and standards for eCOA and RTSM.

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

• Keep up-to-date with emerging technologies in eCOA and RTSM, as well as regulatory trends and best practices.

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

• Serve as a resource for cross-functional teams concerning eCOA and RTSM workflows, timelines, and potential risks.

• May take on additional responsibilities as appropriate based on experience, qualifications, and training.

⛳️ Requirements

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

• 3–5 years of experience in 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 data management principles; familiarity with CDISC is a plus.

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

• Ability to collaborate in cross-functional teams and handle multiple priorities effectively.

• Analytical mindset with excellent problem-solving capabilities.

• Outstanding written and verbal communication skills.

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

• Strong attention to quality and data integrity.

• Technological curiosity and a digital mindset.

• Awareness of problem-solving and escalation processes.

• Effective communication and collaboration with stakeholders.

• Strong organizational skills, accountability, and autonomy.

• Familiarity with good clinical practices and relevant Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

• Must have legal authorization to work in South Africa.

🏝️ Benefits

• Flexible work schedule

• Permanent full-time position

• Ongoing learning and development

• Attractive advancement opportunities

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