eCOA & RTSM Application Specialist

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🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Innovaderm Research Inc.

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201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Act as an eCOA and RTSM subject matter expert during study start-up, maintenance, and close-out • Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions • Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements • Assist with the design of eCOA-related Case Report Forms (CRFs) • Create User Acceptance Testing (UAT) test 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 relevant plans, including DMP and edit check specifications • Prepare study-specific training materials and support training delivery • Lead or participate in internal and sponsor meetings related to system setup, changes, and issue management • Document system configuration and file eCOA and RTSM deliverables into 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 eCOA and RTSM activities comply 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 • Perform other assigned responsibilities when appropriately experienced, qualified, or trained

🎯 Requirements

• 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 able to work in Romania

🏖️ 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

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