Clinical Database Administrator (DBA) (Full Time) Dublin 2, Ireland DescriptionAre 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. 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 and will have the opportunity to establish practice in database quality, innovation, and delivery high quality outputs to support Cancer Trials Ireland studies.
You will work under the management of the Head of Biometrics and 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.
Minimum Requirements1. Third level degree in biomedical/life/computer science or related discipline
2. At least 5 years' experience in a Clinical Data Management environment and an excellent knowledge of data management processes
3. Robust knowledge of Clinical Data Management Systems and Computer System Validation processes
4. Proven experience in Database Administrator activities
5. Ability to analyse and present complex information both written and verbal
6. High level of attention to detail and accuracy
7. Excellent knowledge of and proficiency in all Microsoft Office Tools
8. Excellent organisational, communication and time management skills
9. Proven ability to work independently and on own initiative, but also as part of a team to deliver high quality outputs
Preferred Qualifications1. Relevant professional certifications in database management eg: Medidata Rave Study Builder certification
2. Knowledge of clinical trial study set up in iMedidata Rave
3. Oncology background/experience
4. Experience in R / Python / SAS / C# and other programming languages
5. Knowledge of CDISC Standards CDASH & SDTM
6. 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 ResponsibilitiesPerform and/or support EDC development activities including but not limited to electronic CRF design and edit check programmingLead Computer Systems Validation activities across EDC vendors and Cancer Trials Ireland studies ensuring high quality outputsFor iMedidata Rave – Build studies at study start and implement post production changes during the study via Migrations, Publish checksFor iMedidata Rave - Lead system administration activities: User, Site and Report Administration for all database environmentsMaintenance and oversight of all database configuration documentsServe as main point of contact with EDC vendors and troubleshoot issues within EDC systemProduce and/or review Data Management documentation – such as Case Report Forms, Data Validation SpecificationsReview and assess Data Management processes and reporting tools across Cancer Trial Ireland studiesIdentify process deficiencies and propose improvements to optimise processesContribute to the creation and review of Data Management SOPs and development of EDC Specific work instructionsCreate and maintain study files and other appropriate study DBA documentationCollaborate and support with team members (e.g.: Data Managers, Statistician) to plan and deliver on Study DeliverablesAdhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP, etc. and ensure audit readinessContribute to the preparation and participation in audits and inspectionsPerform other tasks as specified by line manager / Chief Operations OfficerCancer Trials Ireland is fortunate to have a simple purpose around which every member of our widely diverse team can organise: we work together, and collaborate closely, to open and operate new cancer clinical trials in Ireland so that patients here can access the best, most innovative cancer treatments in the world.
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