As Clinical Trials Data Coordinator/DataManager you will work in close partnership with the GHTU team inclose communication with Chief/Principal Investigators and will beresponsible for all aspects of the data management processincluding development of project documentation database setupoverseeing and support data collection and validation dataadministration archiving and sharing.

Your responsibilities willinclude:

General datamanagement:

• Providing datamanagement input on CRFs and contributing to the development oftrial databases and eCRFs for studies.
• Performing QC checks and Database Quality Assessments onclinical databases.
• Monitoring data forconsistency and acceptability reconciling data from externalsources/relational databases.
• Extracting andpreparing data subsets and deriving variables for statisticalanalysis and following procedures for the storage archiving andrecovery of data.

Study involvement:

• Liaising with Chief/Principal investigatorsand statisticians to establish align and confirm data managementexpectations.
• Assisting study teams to monitorthe status of participant data and helping the team develop andreview trial documentation related to data management.
• Working with study teams to review analyse and validateclinical trial data to ensure consistency integrity andaccuracy.
• Supporting the production of regularreports (such as data entry and query progress ofstudies).

GHTUsupport:

• Preparingdata management documentation and drafting project specificdocuments for trials (including Data Management Plans for grantapplications).
• Planning and tracking contentformat and quality of data management deliverables including CRFdesign data validation data quality assessment database lock finaldatasets and archiving.
• Managing and updatingmedical coding dictionaries such as MedDRA and WHODrug.
• Working closely with other members within GHTU to developinternal processes and training staff to ensure compliance and bestpractice adhered to.
• Please refer to the jobdescription for full details on role responsibilities.

Qualifications and skillsrequired:

• A degree orequivalent qualification in a biomedical/scientific/statistical orallied field or commensurate experience in clinical trialdelivery
• Evidence of training in Good ClinicalPractice
• Programming experience in datamanagement such as MS access Excel
• Experienceof working in clinical trials with a particular experience ofworking with clinical data and a good understanding of CRF designand management.
• Experience in developingreports using MSSQL scripts and Microsoft business reportingtools.

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