Title: Clinical Data Manager I (CDM I) Reports to: Senior Clinical Data Manager Cancer Trials Ireland as the HRB National Cancer Clinical Trials Network with host institution Royal College of Surgeons, Ireland (RCSI) has an opening for a Clinical Data Manager. As a leading not-for-profit organisation, Cancer Trials Ireland has the privilege of facilitating investigators and researchers to ask science-driven, rather than profit-driven, research questions. Your role as Clinical Data Manager is key in the Biometrics team and is responsible to lead DM tasks from Start-up to Close-out Activities and collaborate with internal and external team members on all study deliverables from protocol development to database lock. This included creation of database build specifications, leading data cleaning and reporting up to database lock and archiving activities. You are required to be proficiency in Electronic Data Capture (EDC) technical tasks through all stages of a study and have robust knowledge of ICH GCP. You will work under the management of Senior Clinical Data Manager and working closely with Head of Biometrics, Statistics and Clinical Operations teams. This is a flexible role, hybrid or office based in RCSI in Dublin city centre. Key Requirements Third level degree in biomedical/ life science. Minimum of four years of experience in a Clinical Data Management environment. Comprehensive knowledge of data management processes. Experience in clinical data management systems, especially EDC systems such as iMedidata Rave. Excellent communication, organisational and problem-solving skills. Team player as well as ability to work on own initiative. Versatility and ability to work to deadlines. Oncology background/ experience an advantage. Proficiency in all Microsoft Office Tools. Main Function(s) To perform and lead Data Management (DM) tasks on assigned studies within Cancer Trials Ireland. Primary Responsibilities Perform DM tasks on allocated studies from Start-up (e.g. database build specifications) to Close-out Activities (e.g. Database Lock/Archiving) in an effective and efficient manner. Proficiency in EDC technical tasks through all stages of a study. Lead DM activities and collaborate with internal and external team members on all study deliverables from protocol development to Clinical Study Report. Responsible for the DM File and ensuring audit readiness. Adhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP etc ensuring a high-quality standard is maintained for all assigned tasks. Proactively identify DM process improvements and efficiencies and contribute to the creation, review and updating of DM SOPs. If applicable, perform MedDRA coding and utilise other standard DM tools. Review and ensure the quality of work performed by Clinical Data Coordinators/other team members. Train and mentor other team members in relation to DM processes. Attend out of hours meetings from time to time. Perform other tasks as specified by line manager/ CEO.
