Clinical Data Manager (менеджер клинических баз данных)

Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Санкт-Петербург
1–3 года

Brief job description:

Provide Clinical data management support to Clinical Operations team and Biostatistics team. Responsible for generation of high-quality, reliable, and statistically sound data from clinical trials. Assures collection, integration and availability of data at appropriate quality and cost. Supports the conduct, management and analysis of studies across the spectrum of clinical research. The ultimate goal of Clinical Data Manager is to assure that data support conclusions drawn from research.

Primary Responsibilities:

  • During clinical trials planning:
    • Clinical research documents review
    • Data management plan creation
    • Case report form design
    • Computer system and data validation
    • User acceptance testing
  • During clinical trial conduct
    • Regular DB cleaning
    • Data queries generation
    • Serious adverse event reconciliation
    • External vendor data reconciliation
  • During close out
    • Database (DB) lock activities
    • AE, ConMeds Coding
    • DB preparation to statistical analysis
  • Vendor management, Participation in bid defense
  • Standard operating procedures reviewing and creation when need


Required Skills:

  • Bachelor’s degree in a science related field
  • At least 1 (one) year data management and/or related work experience in a pharmaceutical industry
  • Working knowledge of Clinical database applications such as EDC and CTMS.
  • English – Upper Intermediate
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
  • We can also give an excellent opportunity to non-experienced but HIGHLY motivated candidates who wants to find their way in Pharmaceutical industry and Clinical Trials.

Тип занятости

Полная занятость, полный день
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