ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Requirements
- Reviews listings / data visualisation tools / patient profiles with medical data (vital signs, lab data, medical history, concomitant medication, adverse events etc.) for medical plausibility and consistency.
- Supports creation of the Medical Data Review Plan according to standards.
- Reviews Edit Check Plan for appropriate manual and automated medical edit checks and consolidates all medical data review checks.
- Coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF) and CRF Completion Guidelines.
- Reviews and approves all test outputs of listings / visualisations in collaboration with the stakeholders within the project team.
- Participates in or attends internal and client meetings as needed.
- Solves technical problems
- Reviews data for protocol deviations.
- Reviews and responds to Quality Control (QC) findings as needed
- Ensures that medical data review activities are completed within the agreed timelines and meet defined quality standards.
- Documenting Medical Data Review as per SOP.
- Utilizes therapeutic area expertise (e.g. knowledge of RECIST and CTCAE grading on oncology trials) to review clinical data, identify discrepancies, raise and respond to medical queries following through until query resolution.
Benefits
- Annual leave entitlements
- Health insurance
- Retirement planning
- Employee Assistance Programme
- Life assurance
- Country-specific optional benefits