Applications are invited from suitably qualified candidates for a fixed-term contract position as a Clinical Research Data Manager within the HRB Clinical Research Facility at the National University of Ireland, Galway (CRFG).
The position is available immediately for a period of one year, with potential to extend subject to project success and funding acquisition.
The CRFG provides an integrated Data Management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology.
The post holder will provide professional management and co-ordination of clinical research data as well as implementing the latest research-based data management processes as determined by national and international clinical research management bodies.
The role will involve Case Report Form (CRF) development or amendment, data collection, review and discrepancy management to ensure data quality and consistency.
The post holder will contribute to the generation of complex data management solutions resulting in the development of customised research study databases in accordance with the study protocol and regulatory processes.
A variety of profiles will be considered for this post, for example a nurse with IT skills and research experience, a person with an IT background with data management experience or a data manager with IT skills.
Please see for more information on the facility.
Job Description :
The postholder will require a thorough understanding of the entire clinical research process to anticipate and fulfil the data needs of each study.
This will involve working closely with the other members of the team including Principal Investigators to devise the data requirements based upon a clinical trial protocol and manage the creation of Case Report Forms.
The role will involve CRF design and development (both paper and electronic), data collection, review and discrepancy management to ensure data quality and consistency, in accordance with ICH GCP standards.
The successful candidate will contribute to the research and data management functions within the Data Management team, working with clinical staff and CRFG management to establish workloads, timelines and priorities.
Electronic Data Capture of clinical research data in the HRB-CRFG is an essential component of our clinical research activities, managed through a variety of electronic programs.
It is the responsibility of the Clinical Research Data Manager to plan for and resolve any issues that may occur during the capture of data in electronic format as well as ensuring that the data is high quality and delivered for analysis in an accurate and efficient fashion.
The post holder will be expected to support funding submissions process by providing advice on Data Management aspects.
Generate accurate data clarification requests and track all queries through their resolution and filing in the CRF.
Update tracking systems and create / maintain trial master files (TMF) and appropriate study documentation.
Ensure compliance with all ICH-GCP / EU / IRL regulations governing clinical trials.
Assist in standardising data management procedures and data definitions within the department.
Support CRFG research funding submission process by providing advice on Clinical Research Data Management aspects.
Qualifications / Skills required :
Essential Requirements :
Desirable Requirements :
Salary : €37,874 - €43,783 per annum.