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Clinical Safety Data Associate

2 months ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Clinical Safety Data Associate

Everest Clinical Research Services Inc is seeking a skilled and customer-focused individual to join our team as a Clinical Safety Data Associate. This role is responsible for developing study safety data review plans, maintaining data review checklists, and performing safety data reviews according to the Safety Data Review Plan.

Key Responsibilities:
  • Develop study safety data review plans and maintain a standard set of data review checklists for clinical trial laboratory data, AEs, SAEs, medical events of special interests, concomitant medications, disease history, and early study termination due to AEs.
  • Perform safety data review according to the Safety Data Review Plan and review safety data in study database, including the review of laboratory data, AEs, SAEs, medical events of special interests, concomitant medications, disease history, and early study termination due to AEs.
  • Coordinate with study Project Managers and Clinical Data Managers to maintain high-quality data collected in clinical trials.
  • Document, report, and follow-up on all issues identified during the review in a timely manner.
  • Provide medical advice when required to the Clinical Data Managers for their work in reconciling SAEs.
  • Perform coding of AEs/medical histories/concomitant diseases using the MedDRA dictionary.
  • Perform coding of medications (e.g., concomitant medications, concomitant therapies, etc.) using the WHODrug dictionary.
  • Coordinate with Data Managers and ensure medical events and medications collected in study database are coded accurately and on a timely basis.
  • Participate in the trial protocol review and the review of trial Case Report Forms (CRFs) or eCRFs (electronic CRFs) and provide input to the requirements for accurate and consistent approaches in laboratory data collection.
  • Provide medical advice to the Clinical Data Manager with writing the Laboratory Edit Specifications, review the specifications to confirm accuracy, completeness, and ensure consistency across all studies.
  • Review and confirm laboratory normal ranges and units from both central laboratories and local laboratories.
  • Coordinate with and assist the Clinical Data Managers in managing local and central laboratory data and resolve related data issues.
  • Assist the Director of Medical Coding to ensure proper version control of the coding dictionaries and keep track of trial Sponsors' requirements on coding dictionaries and ensure compliance on these requirements.
  • Participate in and contribute to Clinical Data Management initiatives.
  • Provide medical and coding support for programming and biostatistics activities and projects as required and needed.
Qualifications and Experience:
  • RN, M.D., M.Sc., or Ph.D. in Pharmacology or in health-related science, Pharm.D., or equivalent education in relevant disciplines.
  • Two to three years' experience in clinical trial data management, including medical coding and laboratory data management.
  • A broad knowledge in clinical trial safety data coding and management.
  • Demonstrated ability to effectively manage medical information; must communicate effectively, orally and in writing, with personnel on all professional and administrative levels; must be well organized and able to work independently and manage multiple projects/tasks appropriately.