**Job Title:** Clinical Data Co-ordinator
Reports to: Senior Clinical Data Manager
Key Requirements:
* Third level degree in biomedical/life science or related discipline.
* Proficiency in all Microsoft Office Tools and general computer literacy.
* Good organisational, communication and time management skills.
* Ability to exercise good attention to detail.
* Team player as well as ability to work on own initiative and work to deadlines.
Experience in a Clinical Data Management environment or with EDC systems such as iMedidata Rave is an advantage. Experience in data analytics is also an advantage (e.g. Power BI, Python). Oncology background/relevant medical experience is an advantage.
**Main Function(s):** To perform Clinical Data Co-ordinator tasks on assigned studies within Cancer Trials Ireland in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, clinical study protocols and study-specific procedures.
**Primary Responsibilities:**
* Perform Data Management (DM) tasks on allocated studies from Start-up (e.g. database build) to Close-out Activities (e.g. Database Lock/Archiving).
* Support the development and testing of clinical trial Case Report Forms (CRFs), databases and edit specifications.
* Review CRF/eCRF data for completeness, accuracy, and consistency via computerised edits, manual and programmed data checks.
* Ensure data quality, integrity and compliance with regulatory standards.
* Participate in DM meetings with internal Cross Functional team members (e.g. Pharmacovigilance, Clinical Operations, Statistics etc.) and external stakeholders.
* Collaborate with team members to plan and deliver on Study Deliverables.
* Support in maintaining the Data Management File and ensuring audit readiness.
* Provide additional administrative support to the Biometrics department and perform office administration tasks where required.
* Perform other tasks as specified by the line manager.