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About the Role
hVIVO is seeking a Data Associate to join on a permanent contract based at our London site in Canary Wharf.
hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methodologies across differing viral challenges. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely - or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
Responsibilities
- Support Project Data Managers with assigned study activities such as document creation and QC review, study filing, data reconciliation, query management, and status reporting.
- Enter study data into data management or other allied systems under the supervision of the relevant Project Data Manager and Senior Manager, Data Management.
- Ensure the accuracy of the data entry and ensure entries match the source data by performing self-checks of own entry and formal quality control checks on other staff's entries as allocated.
- Enter data into the source data collection system/clinical data management system.
- Check data already entered is accurate and consistent with the original source data.
- Ensure quality control of data entry.
- Complete, update, and maintain spreadsheets and tracking systems as required.
- Report progress of data entry, data reviews, and query status to the Project Data Manager/hData Management.
- Collate and distribute accurate data to relevant parties.
- Assist in the timely resolution of data queries.
- Help in the generation and review of study documents and processes.
- Provide support to the Project Data Managers for their assigned projects.
- Assembly of source casebooks for delivery to site.
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Requirements
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- Degree or equivalent
- Good organisational skills
- Familiarity with medical terminology
- Ability to work within a project team with minimal supervision
- Good knowledge in ICH-GCP and other relevant regulations/guidelines
- Knowledge/experience in Clinical eSource collection systems
- A good working knowledge of Microsoft Office programmes
- Good attention to detail
- Experience in data handling and understanding the importance of working in a controlled and structured environment
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