Clinical Trials Data Coordinator

As Clinical Trials Data Coordinator/Data Manager, you will work in close partnership with the GHTU team in close communication with Chief/Principal Investigators and will be responsible for all aspects of the data management process, including development of project documentation, database set-up, overseeing and support data collection and validation, data administration, archiving and sharing.

Your responsibilities will include:

General data management:

• Providing data management input on CRFs and contributing to the development of trial databases and eCRFs for studies.
• Performing QC checks and Database Quality Assessments on clinical databases.
• Monitoring data for consistency and acceptability, reconciling data from external sources/relational databases.
• Extracting and preparing data subsets and deriving variables for statistical analysis, and following procedures for the storage, archiving and recovery of data.

Study involvement:

• Liaising with Chief/Principal investigators and statisticians to establish, align and confirm data management expectations.
• Assisting study teams to monitor the status of participant data, and helping the team develop and review trial documentation related to data management.
• Working with study teams to review, analyse and validate clinical trial data to ensure consistency, integrity and accuracy.
• Supporting the production of regular reports (such as data entry and query progress of studies).

GHTU support:

• Preparing data management documentation and drafting project specific documents for trials (including Data Management Plans for grant applications).
• Planning and tracking content, format and quality of data management deliverables, including CRF design, data validation, data quality assessment, database lock, final datasets and archiving.
• Managing and updating medical coding dictionaries such as MedDRA and WHODrug.
• Working closely with other members within GHTU to develop internal processes, and training staff to ensure compliance and best practice adhered to.

Qualifications and skills required:

• A degree or equivalent qualification in a biomedical/scientific/statistical or allied field, or commensurate experience in clinical trial delivery.
• Evidence of training in Good Clinical Practice.
• Programming experience in data management such as MS Access, Excel.
• Experience of working in clinical trials, with a particular experience of working with clinical data and a good understanding of CRF design and management.
• Experience in developing reports using MSSQL scripts and Microsoft business reporting tools.