Are you a database administrator interested in Clinical Research? 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 Database Administrator. 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 Database Administrator is key in the Biometrics team and is responsible for the delivery of all technical tasks in our Electronic Data Capture (EDC) system. This includes database design, build, and validation in addition to system administration and database revisions. You are responsible for the timely resolution of technical issues will have the opportunity to establish practice in database quality, innovation, and delivery high quality outputs to supportCancer Trials Ireland studies. You will work under the management of the Head of Biometrics and working closely with Statistics, Data Management and Clinical Operations teams. This is a fully flexible role; you can work from home full time or hybrid in our office in RCSI in Dublin city centre. Title: Clinical Database Administrator (DBA) Reports to: Head of Biometrics Essential Requirements Third level degree in biomedical/life/computer science or related discipline At least 5 years experience in a Clinical Data Management environment and an excellent knowledge of data management processes Robust knowledge of Clinical Data Management Systems and Computer System Validation processes Proven experience in Database Administrator activities Ability to analyse and present complex information both written and verbal High level of attention to detail and accuracy Excellent knowledge of and proficiency in all Microsoft Office Tools Excellent organisational, communication and time management skills Proven ability to work independently and on own initiative, but also as part of a team to deliver high quality outputs Desirable Requirements Relevant professional certifications in database management eg: certification Knowledge of clinical trial study set up in iMedidata Rave Oncology background/experience Experience in R / Python / SAS / C# and other programming language Knowledge of CDISC Standards CDASH & SDTM Software experience eg: SaaS/Cloud Main Function(s) Responsible for all technical tasks for database design, build, validation, and maintenance of Electronic Data Capture (EDC) systems including system administration, database revisions and timely resolution of technical issues related to all stages of Cancer Trials Ireland studies. Primary Responsibilities Perform and/or support EDC development activities including but not limited to electronic CRF design and edit check programming Lead Computer Systems Validation activities across EDC vendors and Cancer Trials Ireland studies ensuring high quality outputs For iMedidata Rave Build studies at study start and implement post production changes during the study via Migrations, Publish checks For iMedidata Rave - Lead system administration activities: User, Site and Report Administration for all database environments Maintenance and oversight of all database configuration documents Serve as main point of contact with EDC vendors and trouble shoot issues within EDC system Produce and/or review Data Management documentation such as Case Report Forms, Data Validation Specifications Review and assess Data Management processes and reporting tools across Cancer Trial Ireland studies Identify process deficiencies and propose improvements to optimise processes Contribute to the creation and review of Data Management SOPs and development of EDC Specific work instructions Create and maintain study files and other appropriate study DBA documentation Collaborate and support with team members (e.g.: Data Managers, Statistician) to plan and deliver on Study Deliverables Adhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP, etc. andensure audit readiness Contribute to the preparation and participation in audits and inspections Perform other tasks as specified by line manager / Chief Operations Officer
