eCOA & RTSM Application Specialist

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

📋 Description

• Serve as a subject matter expert for eCOA and RTSM during the phases of study initiation, ongoing management, and completion.

• Outline functional requirements and engage in the design and configuration of eCOA and RTSM solutions.

• Write and update system specifications, user requirements, edit checks, notifications, and reporting needs.

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

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

• Verify eCOA logic, rules, and study calculations against protocol specifications.

• Assist with CDISC-compliant data mapping and work alongside Clinical Data Standards teams.

• Contribute to data cleaning strategies and review pertinent plans, including Data Management Plans (DMP) and edit check specifications.

• Create training materials specific to the study and support the delivery of training sessions.

• Lead or take part in internal and sponsor meetings concerning system setup, modifications, and issue resolution.

• Record system configurations and upload eCOA and RTSM deliverables into the Trial Master File (TMF).

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

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

• Guarantee that eCOA and RTSM activities adhere to ICH-GCP, FDA, EMA, and other pertinent regulatory standards.

• Assist in the creation 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.

• Stay informed about new eCOA and RTSM technologies, regulatory developments, and best practices.

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

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

• Undertake other assigned responsibilities when suitably experienced, qualified, or trained.

⛳️ Requirements

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

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

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

• Strong grasp of clinical trial processes and data management principles; familiarity with CDISC is advantageous.

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

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

• Analytical mindset with robust problem-solving capabilities.

• Exceptional written and verbal communication skills.

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

• Meticulous attention to quality and data integrity.

• Technical curiosity and a digital mindset.

• Awareness of problem-solving and escalation processes.

• Proficient in stakeholder communication and collaboration.

• Strong organizational skills, accountability, and independence.

• Good understanding of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal eligibility to work in Romania.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Opportunities for ongoing learning and development.

• Attractive prospects for career advancement.

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