Job Description

Insights Research Organization & Solutions (IROS) is the UAE’s first homegrown Contract Research Organization (CRO) dedicated to advancing healthcare research. By delivering world-class clinical trials, data-driven solutions, and regulatory expertise, IROS empowers innovation, accelerates drug and therapy development, and strengthens the region’s role in shaping the future of global healthcare.

We are seeking an experienced and proactive Clinical Data Manager to join our growing team at IROS. In this role, you will act as the primary data management point of contact for assigned studies, overseeing end-to-end clinical data management activities from study start-up through database lock. You will work closely with internal teams, sponsors and external vendors to ensure high-quality data delivery, regulatory compliance and efficient study execution.

Responsibilities

• Serve as the primary data management lead for assigned clinical trials, including sponsor-facing responsibilities and ownership of data management deliverables.
• Lead and coordinate the design, development, testing and deployment of EDC systems with vendors, ensuring timelines and quality standards are met.
• Develop and design eCRFs and edit checks; contribute to rapid CRF generation post-protocol finalisation.
• Conduct UAT activities in collaboration with vendors and internal stakeholders.
• Draft and maintain Data Management Plans, CRF Completion Guidelines, Edit Check Specifications and Data Review Plans.
• Establish, track and manage external data streams (eg. central labs, ECG, imaging, ePRO), including setup of Data Transfer Agreements.
• Perform regular data reviews, discrepancy management and issue resolution in collaboration with internal teams.
• Lead database lock and archival activities, ensuring documentation is inspection ready.
• Monitor and ensure timely data collection, coding (MedDRA/WHODrug) and cleaning in accordance with study timelines.
• Participate in protocol reviews, SAP reviews, CSR development and timeline discussions.
• Support GCP inspections and external audits, representing the data management function as needed.
• Ensure compliance with relevant ICH-GCP, 21 CFR Part 11, CDISC (CDASH, SDTM) and sponsor-specific standards.
  

Qualifications

• Bachelor’s degree in a life science, health science, computer science, or related field.
• Minimum of 4 years’ experience in clinical data management, preferably in a CRO or sponsor-facing environment.
• Experience as lead data manager on several full-service studies is required.