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Clinical Data Manager

2 months ago

London, Greater London, United Kingdom Lifelancer Full time
Job Description

Lifelancer is seeking a highly skilled Clinical Data Manager to join our team and support our clients in the pharmaceutical industry. As a Clinical Data Manager, you will be responsible for delivering high-quality data management activities for clinical trials from study set-up to close-out, ensuring compliance with Good Clinical Practice (GCP) and applicable regulatory guidance.

Main Responsibilities:
  • Leadership: Provide data management leadership and expertise as a core member of the Clinical Trial Team.
  • Study Set-Up:
    • eCRF set-up and user acceptance testing (UATs)
    • Development and review of study plans and documents
    • Organize and conduct strategy meetings with the study team
    • Interaction with external vendors
  • Study Conduct/Closure:
    • Manage data validation and queries
    • Review data reports and implement corrective actions
    • Handle third-party data loading and reconciliation
    • Organize and conduct data review and database lock meetings
    • eTMF archiving
    • Vendor Management: Maintain a good working relationship with external vendors and monitor their performance. Implement mitigation actions as necessary.
    Qualifications:
    • Bachelor's, Master's, or PhD degree in life sciences, mathematics, or a related area
    • For Junior role: 1-3 years of Clinical Data Management experience, preferably in Phase 1 and Phase 2 studies
    • For Manager role: 5-8 years of Clinical Data Management experience
    • For Senior Manager role: years of Clinical Data Management experience
    • Knowledge of Clinical Trial Development Processes and ICH-GCP
    • Strong communication and interpersonal skills
    • Experience with clinical study management tools and systems
    • Ability to manage multiple external data systems
    • Proficiency in Microsoft Office
    • Fluent in English (written and spoken)