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About the Role

This opportunity is with a partner company based in Canada seeking a Clinical Safety Data Associate to support global clinical research programs. The principal focus is to ensure the integrity, consistency, and high quality of safety data collected during clinical trials. The position combines medical knowledge, data management capabilities, and collaboration within multidisciplinary teams to enhance clinical development with patient safety priorities.

Responsibilities

Create and uphold safety data review protocols including standard checklists to cover laboratory results, adverse events, serious adverse events, special medical events, medications, disease histories, and study termination data.
Perform detailed reviews of safety data per established procedures, identify discrepancies, document findings, and ensure resolution completion.
Work closely with Project Managers, Clinical Data Managers, and other stakeholders to maintain data quality and regulatory compliance.
Provide clinical expertise and guidance during serious adverse event reconciliation activities as needed.
Conduct medical coding of adverse events, medical histories, and concurrent diseases leveraging MedDRA terminology.
Code medication information accurately and promptly using WHODrug dictionaries.
Support clinical trial protocol assessments and case report form (CRF/eCRF) reviews to improve data collection consistency.
Offer input on laboratory edit specifications to ensure data completeness, accuracy, and alignment across multiple studies.
Review and resolve inconsistencies in laboratory normal ranges and units obtained from central and local labs.
Assist Clinical Data Managers with laboratory data handling and problem resolution.
Support management of coding dictionary versions with strict adherence to study-specific requirements.
Contribute to Clinical Data Management initiatives and provide medical and coding assistance for programming and biostatistics tasks when required.

Qualifications

Degree (Bachelor's, Master's, or Doctorate) in health-related fields such as Nursing, Medicine, Pharmacology, Pharmacy, Biomedical Sciences, or equivalent disciplines.
2 to 3 years of practical experience in clinical trial data management, including medical coding and managing laboratory data.
Comprehensive knowledge of clinical trial safety data workflows, medical coding standards, and data review techniques.
Experience using coding dictionaries like MedDRA and WHODrug.
Strong skills in accurate medical information management with an emphasis on documentation quality.
Excellent organizational abilities for handling multiple priorities and independent project management.
Effective communication skills in both written and verbal forms to collaborate across clinical, medical, and administrative sectors.
Detail-oriented analytical aptitude for thorough review of complex clinical data sets.

Benefits

Competitive salary estimated between CAD 60000 and 80000 annually.
Comprehensive health benefits including medical, dental, and vision insurance.
Life insurance and accidental death and dismemberment coverage.
Short-term and long-term disability insurance.
Tuition reimbursement to support continuing education.
Fitness program reimbursement.
Employee Assistance Program (EAP) support services.
Pension plan participation.
Generous paid leave including vacation and sick days.
Opportunities for performance-related bonuses.
Flexible work arrangements allowing fully remote work from anywhere in Canada.

Additional Information

The recruitment process utilizes AI-powered matching technology to efficiently and objectively identify top candidates for the role. Subsequent selection steps and communications are managed directly by the hiring organization. Applicant data is processed in accordance with privacy regulations, including GDPR where applicable, with applicant rights to data access and correction respected. AI tools assist in application assessments but final hiring decisions remain human-led.

Clinical Safety Data Associate