Clinical Trials Data Manager

2 months ago

Liverpool, Liverpool, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly skilled Clinical Trials Data Manager to join our team at Lifelancer. As a Clinical Trials Data Manager, you will play a critical role in the success of our clinical trials by ensuring the accuracy, integrity, and quality of clinical trial data.

Key Responsibilities
  • Data Management
    • Provide data management input on Case Report Forms (CRFs) and contribute to the development of trial databases and electronic CRFs (eCRFs) for studies.
    • Perform Quality Control (QC) checks and Database Quality Assessments on clinical databases.
    • Monitor data for consistency and acceptability, reconciling data from external sources/relational databases.
    • Extract and prepare data subsets and derive variables for statistical analysis, following procedures for the storage, archiving, and recovery of data.
  • Study Involvement
    • Liaise with Chief/Principal Investigators and statisticians to establish, align, and confirm data management expectations.
    • Assist study teams to monitor the status of participant data and help the team develop and review trial documentation related to data management.
    • Work with study teams to review, analyze, and validate clinical trial data to ensure consistency, integrity, and accuracy.
    • Support the production of regular reports (such as data entry and query progress of studies).
  • GHTU Support
    • Prepare data management documentation and draft project-specific documents for trials (including Data Management Plans for grant applications).
    • Plan and track content, format, and quality of data management deliverables, including CRF design, data validation, data quality assessment, database lock, final datasets, and archiving.
    • Manage and update medical coding dictionaries, such as MedDRA and WHODrug.
    • Work closely with other members within GHTU to develop internal processes and train staff to ensure compliance and best practice adherence.
    Requirements
    • A degree or equivalent qualification in a biomedical/scientific/statistical or allied field or commensurate experience in clinical trial delivery.
    • Strong self-sufficiency and initiative working on MSSQL database.
    • 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.
    • Experience of working in clinical trials, with 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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