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Clinical Trials Data Manager

2 months ago

Liverpool, United States Lifelancer Full time

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:

Generaldata management:

  • Providing data management input on CRFs and contributingto the development of trial databases and eCRFs forstudies.
  • Performing QC checks and DatabaseQuality Assessments on clinical databases.
  • Monitoring data for consistency and acceptabilityreconciling data from external sources/relationaldatabases.
  • Extracting and preparing datasubsets and deriving variables for statistical analysis andfollowing procedures for the storage archiving and recovery ofdata.

Studyinvolvement:

  • Liaisingwith Chief/Principal investigators and statisticians to establishalign and confirm data management expectations.
  • Assisting study teams to monitor the status ofparticipant data and helping the team develop and review trialdocumentation 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
  • Strong selfsufficiency and initiativeworking on MSSQL database Data Manager
  • Evidence of training in Good Clinical Practice
  • Programming experience in data management such as MSaccess Excel
  • Programming experience in datamanagement such as MS SQL SAS Stata etc Data Manager
  • Experience of working in clinical trials with aparticular experience of working with clinical data and a goodunderstanding of CRF design and management.
  • Experience in developing reports using MSSQL scripts andMicrosoft business reporting tools.

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