About this role
About the Role As a CDC II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments. You will deliver clinical data management work to a high standard, collaborating with the DM team and trial partners to ensure data quality and integrity throughout the trial lifecycle. What You'll Do
- Planning, coordination, and risk assessment of data review using various tools and technologies. Defines data review requirements for the trial with input to and from the RACT, in collaboration with Trial Partners.
- Collaborate with programmers to set up data review tools; maintain overview of data review status and communicate progress to the CTDM.
- Work with Trial Partners and stakeholders to deliver data review deliverables; participate in process and toolkit improvement projects to evolve data review processes.
- Drive risk-based data management approaches to data review; monitor data quality, issue trends, and report to PoC.
- Ensure clinical data meets regulatory requirements, quality and data standards; ensure DM activities comply with internal and external requirements.
- Provide input to the Risk Assessment Categorization Tool (RACT); maintain relationships with DM trial partners.
- Review clinical data in various formats, raise and close queries with EDC/CDMS; create DMM, write specs for DMM and other review plans as needed; review large datasets for accuracy.
- Identify and rectify errors, develop and implement data review checks, contribute to dashboards, visualize data findings, and support operational decisions.
- Maintain trial documentation and archival; participate in audits and inspections; assist DM Study Lead with eCRF maintenance, data validation specs, and study procedures.
- Manage data reconciliation and track study/task metrics; address data questions and identify root causes to resolve issues. What We're Looking For
- Bachelor's degree in Life Sciences or Healthcare.
- Intermediate knowledge of clinical data management within the pharmaceutical or biotechnology industry.
- Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
- Strong attention to detail; ability to work in a fast paced environment.
- Excellent communication and collaboration with cross functional teams.
- Knowledge of regulatory guidelines and standards (ICH-GCP) is a plus. Nice to Have
- Familiarity with RACT and risk based data review approaches.
- Experience with EDC/CDMS, data visualization dashboards, and audit readiness. Compensation & Benefits
- Benefits include various annual leave entitlements, health insurance offerings, retirement planning, and LifeWorks Global EAP with 24/7 access to professionals.
- Life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, gym discounts, travel discounts, health assessments).
- ICON is committed to inclusion and equal opportunity; details available on the careers site.