Job Description

The main purpose of the role will be to:

• Provide operational support within the clinical trial unit; taking responsibility for data management during study conduct and closure, assist with data management study set-up activities and delivering to key milestones for a series of grant-funded single and multi-Centre clinical studies managed through the Unit.
• Assist research teams with Serious Adverse Event reporting, database and case report form (CRF) review, data management component testing, contributing to the development and maintenance of study documentation and the preparation of periodic safety reports on clinical study data and follow-up.
• Contribute to the wider development of the unit, and to the training, and mentoring of new team members and colleagues.
• Be responsible for the data management of specific investigator-led clinical studies as determined by the Data Management Team Lead.
• Review and maintain data management documentation, record management systems and tracking tools for clinical studies.
• Assist in the review and approval of study case report forms (CRFs) and related databases for collection and storage of study data.
• Update databases with data from CRFs, questionnaires, sample files and other electronic and paper sources, including liaison with data providers.
• Highlight when CRF, database and document amendments are required, produce tabulations, summary information and extracts of data to assist in analyses in collaboration with statisticians and others within the study teamand external partners.
• Organize development and review meetings and contribute to progress meetings.
• Provide data and assistance to external and internal auditors/monitors as required.
• Create and maintain reporting mechanisms to establish adequate data flow, and support related metric reports and escalation of issues.
• Assist with study initiation at participating Centre’s.

Required Knowledge, Skills, and Abilities

Educated to a degree level in a scientific discipline and relevant experience in scientific and medical research. A proven experience in data handling within the clinical study process. Experience working ina delivery focused environment. Competent using databases and office systems (spreadsheets, word publisher, internet & email). Knowledge of clinical research requirements and the clinical study life cycle as well as sound knowledge of GCP guidelines and EU directives as applied to data management activities and standards. Able to deliver to tight and/or unexpected deadlines.