Manager Clinical Data Management

Job summary

Lead and perform clinical trial data management activities, including database and Case Report Form design, data validation, query management, quality control, and database closure. Coordinate study milestones, train and supervise staff and site monitors, prepare progress reports, resolve coding discrepancies, and maintain trial documentation and archives.

Job details

About Our Client Location: Toronto/Markham, Ontario, Canada (On-site) or Remote within Canada Employment Type: Full-time Our client is an established, full-service healthcare and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in clinical data management and statistical services, the organization provides comprehensive clinical trial support across multiple therapeutic areas and international markets. Position Overview We are recruiting Clinical Data Manager on behalf of our client. The successful candidates will be responsible for leading and performing clinical trial data management activities, ensuring data accuracy, quality, and compliance with applicable regulatory requirements and project timelines. The position is based on-site in Toronto/Markham, Ontario, or remotely from a home-based office anywhere in Canada, subject to the client's Work from Home policy. Key Responsibilities Plan, manage, and perform clinical trial data processing and management activities in accordance with sponsor requirements, quality standards, and established timelines. Lead assigned data management projects, coordinate study activities, and monitor project milestones. Develop and maintain database validation checks for common database modules and therapeutic-specific requirements. Monitor clinical trial dataflow and quality control (QC) processes in accordance with SOPs, Good Working Practices, and departmental guidelines. Design and review Case Report Forms (CRFs) and database schemas, and test data capture and entry screens. Validate electronically captured clinical data and generate queries for missing, inconsistent, or out-of-range information. Develop and maintain standard query libraries for common database modules and therapeutic-specific requirements. Perform ongoing database QC and final database closure checks at study completion. Train and supervise data entry staff and junior data management personnel on study procedures and data management practices. Prepare, validate, and distribute study progress reports to internal and external stakeholders. Assist in resolving discrepancies related to the coding of medical events, treatment procedures, and medications. Maintain study documentation and support the final archiving of clinical trial data and related records. Collaborate with Quality Assurance (QA) personnel on quality reviews of CRFs, database schemas, and clinical trial databases. Train clinical trial site monitors on dataflow and quality control processes. Qualifications and Experience Bachelor's degree in health or pharmaceutical sciences, physical or biological sciences, chemistry, or a related field, with at least 2 years of experience in clinical trial data capture and management; or a Master's or Ph.D. in a relevant field with at least 1 year of relevant experience. Strong understanding of clinical trial data management concepts, processes, and procedures, including applicable pharmaceutical regulations, industry guidance, conventions, and standards. Demonstrated leadership in clinical data management activities, with the ability and motivation to lead data management projects and coordinate study-related activities. Benefits and Compensation Our client offers a comprehensive benefits package that includes medical, dental, and vision coverage; life and AD&D insurance; short- and long-term disability coverage; tuition reimbursement; fitness reimbursement; an Employee Assistance Program (EAP); a pension plan; generous paid time off and sick leave; and eligibility for a performance-based bonus. Complete your application here: https://dawnjobapp.com/ViewJob/9906

What you’ll do

Lead and perform clinical trial data management activities, including database and Case Report Form design, data validation, query management, quality control, and database closure. Coordinate study milestones, train and supervise staff and site monitors, prepare progress reports, resolve coding discrepancies, and maintain trial documentation and archives.

Requirements

Requires a bachelor's degree in a relevant scientific or health-related field and at least two years of clinical trial data capture and management experience, or a master's or Ph.D. with at least one year of relevant experience. Candidates should understand clinical data management processes and applicable regulations and standards, and demonstrate the ability to lead projects and coordinate study activities.

Benefits

• Medical Coverage
• Dental Coverage
• Vision Coverage
• Life Insurance
• Accidental Death and Dismemberment Insurance
• Short-Term Disability Coverage
• Long-Term Disability Coverage
• Tuition Reimbursement
• Fitness Reimbursement
• Employee Assistance Program
• Pension Plan
• Paid Time Off
• Sick Leave
• Performance-Based Bonus

Listed skills

• Regulatory Compliance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Data Management
• Clinical Trial Data Processing
• Project Leadership
• Study Coordination
• Database Validation
• Data Quality Control
• Case Report Form Design
• Database Schema Design
• Electronic Data Capture
• Query Management
• Database Quality Control
• Clinical Data Coding
• Progress Reporting
• Staff Training and Supervision
• Regulatory Compliance
• Clinical Trial Documentation

Job areas

• Healthcare
• Management & Leadership
• Data & Analytics
• Science & Research

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