Role Description The Quality Assistance1 role supports the operational quality and documentation management of clinical trials across CDC and adjacent affiliate countries. This position ensures compliance with regulatory requirements, SOPs, and internal processes while supporting effective trial execution, quality oversight, and coordination across cross-functional teams. What You Will Do: - Trial Documentation & eTMF Management: - Oversee clinical trial documentation, including CTA packages for Health Authority (HA) and Ethics Committee (EC) submissions. - Maintain and ensure compliance of the electronic Trial Master File (eTMF), including timely uploads, quality checks, and archiving at study closeout. - Support investigator TMF setup and documentation completeness. - Quality Oversight & Compliance: - Perform compliance checks and process reviews across clinical study activities (e.g., regulatory, feasibility, study start-up, contracts, and trial management). - Ensure adherence to SOPs, local procedures, and regulatory requirements. - Document findings and track follow-up actions to closure. - SOP Deviations Management: - Review and follow up on SOP deviations to ensure accuracy, completeness, and timely resolution. - Act as system owner for cross-study or multi-site deviations. - Coordinate stakeholders, track actions, and support deviation trending and reporting. - Quality Metrics & Reporting: - Support collection, consolidation, and tracking of quality metrics. - Maintain organized documentation and contribute to dashboards and internal reports. - Clinical Trial Operations Support: - Assist with trial-related payments and invoice processing. - Support local safety reporting activities. - Provide administrative and system support (e.g., super user tasks as applicable). - Training & Team Coordination: - Maintain training guides and training matrices, ensuring alignment with role requirements. - Track training completion and identify gaps. - Coordinate team meetings and support knowledge sharing across the team. - Cross-functional Collaboration: - Partner with CDC, local clinical teams, and other stakeholders to ensure successful trial planning and execution. - Drive consistency in processes and eTMF handling across affiliate countries. Qualifications - Less than 2 years of relevant experience in clinical operations, quality support, or similar roles. - Basic understanding of clinical trial processes, documentation, and regulatory requirements. - Familiarity with eTMF systems, SOPs, and quality/compliance practices is an advantage. - Strong organizational skills and attention to detail, with the ability to manage multiple tasks. - Good communication and coordination skills, with a collaborative approach to cross-functional work. - Ability to track, document, and follow up on activities in a structured and timely manner. - Proficiency in administrative tools and systems (e.g., document management, tracking systems). Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.