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Clinical Data Analyst

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About the role

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Clinical Data Analyst


 


Overview of the role


 


Responsible for reviewing data based on the Clinical Data Analysis (CDA) plan for one or more studies



  • Create a study specific CDA plan

  • Review study data accurately to identify site performance issues

  • Communicate effectively with the project team, CRAs, DM Staff, Medical staff, Scientific Council to ensure adequate monitoring intervention and effective resolution of site performance issues

  • Work with Data Management, Clinical Operations, Central Laboratory, ITG, Biostatistics, Medical Writing, Regulatory Affairs and Quality Assurance to ensure all data collected within a clinical study are managed according to corporate standards and meet regulatory guidelines for data integrity

  • Fulfil the job function in accordance with Good Clinical Practice (GCPs), ICON Standard Operations Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs), International Committee of Harmonization (ICH), and all applicable laws and regulations


Role Requirements


 


•           The ideal candidate will have at least 3-4 years clinical data management or clinical research associate (CRA) experience


•           Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience


•           Knowledge of regulatory requirements respecting data quality and clinical trials conduct.


•           Excellent oral communication skill.


•           Excellent accuracy and attentiveness to detail


•           Proven leadership skills and the ability to work independently to resolve study related issues


•           Ability to work within a team environment


•           Ability to manage competing priorities in a changeable environment.


•           Knowledge of database technologies and processes


•           Ability to handle stressful situations and deadlines


•           Excellent interpersonal skills


 


Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s licence


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