[Hiring] Clinical Data Management Specialist @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Clinical Data Management Specialist for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

• Perform data entry and processing activities for assigned projects in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
• Assist the primary Data Manager in performing data management activities, including:
  • Writing Data Management Plans (DMP; including specifying database integrity checks)
  • Designing clinical trial Case Report Forms (CRFs)
  • Designing databases
  • Monitoring data flow
  • Quality control processes
• Write draft DMPs using standard DMP template.
• Assist in defining and monitoring clinical trial data flow and quality control processes in accordance with corporate standard operating procedures (SOPs), Good Working Practices, and divisional guidelines.
• Assist in designing and reviewing patient CRFs and database schema. Test data capture/entry screens and edit specifications.
• Assist in designing databases following established design standards and conventions.
• Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
• Assist in performing data quality control procedures during the trial and additional database closure checks at the end of the study.
• Validate and distribute study monitoring reports to internal and external study team members.
• Assist in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medications.
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving such documentation.
• Assist data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies, including:
  • Performing line-by-line checks on subject data listings against completed CRFs
  • Comparing database schema against annotated CRFs
  • Comparing final paper CRFs against CRF images captured during the trial

Qualifications

• A Bachelors’ or Masters’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• Education or experience must demonstrate the ability to work independently and to apply data management concepts, clinical trial data capture and management techniques, and logical and algebraic operations.

Benefits

• Robust benefits package to support health, well-being, and growth, including:
  • Medical, dental, and vision coverage
  • Life & AD&D insurance
  • Short- and long-term disability
  • Tuition reimbursement
  • Fitness reimbursement
  • Employee assistance program (EAP)
  • Pension plan
  • Generous paid time off and sick leave
  • Opportunity to earn a performance-based bonus
• Estimated Salary Range: $45,000 - $70,000.