Clinical Trials Data Manager

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 setup 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.
• Please refer to the job description for full details on role responsibilities.

Qualifications and skills required:

• A degree or equivalent qualification in a biomedical/scientific/statistical or allied field or commensurate experience in clinical trial delivery
• Strong selfsufficiency and initiative working on MSSQL database Data Manager
• Evidence of training in Good Clinical Practice
• Programming experience in data management such as MS access Excel
• Programming experience in data management such as MS SQL SAS Stata etc Data Manager
• 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.

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Remote Work :

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