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Senior Clinical Data Analyst

hace 1 mes

Medellín, Antioquia, Colombia Parexel A tiempo completo
Job Summary

Parexel is seeking a highly skilled Senior Clinical Data Analyst to support our FSP team. This is a remote role, open to candidates based in Argentina, Brazil, Mexico, and Colombia.

Key Responsibilities
  • Independently perform and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy.
  • Provide technical expertise and/or operational leadership regarding all DM operational activities, processes, and Data Management documents regarding data validation.
  • Act as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors.
  • May act as a back-up to or fulfill the Data Management Lead role where required.
Requirements
  • Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
  • Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
  • Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements, and PAREXEL SOPs and study specific procedures.
  • Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase).
  • Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
  • Experience in clinical research industry.
  • Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG).
  • Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct, and close-out.
  • Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation.
  • Basic knowledge of SAS (programmed listings).
  • Basic knowledge of Data standards (CDISC).
  • Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.
  • Proven experience of leading virtual/global Data Management operational team/s to perform DB set up, data cleaning activities.
Education

Bachelor's degree and/or other medical qualifications or relevant industry experience.