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Clinical Compliance Specialist - Job Opportunity at Alimentiv

Winnipeg, Canada
Full-time
Senior
Posted: April 18, 2025
On-site
CAD 76,000-127,000 per year

Benefits

Competitive salary range indicating strong market positioning
Professional development opportunities in clinical research
Work in regulated healthcare environment

Key Responsibilities

Lead quality issue management and resolution processes with 40% focus
Conduct and oversee site audits and inspection readiness (20%)
Manage training compliance and oversight (15%)
Drive continuous improvement initiatives and compliance monitoring (25%)
Provide expert guidance on ICH GCP and regulatory standards
Partner with study delivery teams on quality assurance
Facilitate quality issue investigations and CAPA implementation
Support audit preparation and execution
Develop and monitor key performance indicators

Requirements

Education

Bachelors Degree

Experience

7+ years of related experience

Required Skills

Expertise in root cause methodologies Knowledge of ICH-GCP principles, ISO 20916 and ISO 14155 Strong interpersonal and communication skills Superior analytical skills Critical thinking Quality by Design principles knowledge
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Sauge AI Market Intelligence

Industry Trends

Clinical research compliance roles are experiencing increased demand due to growing regulatory complexity and focus on data integrity Shift towards risk-based quality management systems is creating need for more sophisticated compliance approaches Integration of technology in clinical trials is driving need for broader technical competency in compliance roles

Salary Evaluation

The offered salary range of CAD 76,000-127,000 is competitive for the Canadian market, reflecting the senior nature and specialized expertise required for the role

Role Significance

Typically operates within a specialized quality/compliance team of 5-10 professionals, interfacing with broader clinical operations teams
Senior individual contributor role with significant influence on organizational risk management and quality outcomes

Key Projects

Implementation of quality management systems Regulatory inspection preparation and management Clinical trial quality oversight programs Process improvement initiatives

Success Factors

Deep understanding of clinical research regulations and ability to interpret evolving requirements Strong investigative and analytical capabilities for issue resolution Excellent stakeholder management skills across multiple organizational levels Ability to balance quality requirements with operational efficiency

Market Demand

High demand due to increasing regulatory requirements in clinical research and limited pool of experienced compliance professionals

Important Skills

Critical Skills

Regulatory knowledge (ICH GCP, ISO standards) - Essential for ensuring compliance and risk management Quality management systems expertise - Core to role effectiveness and process improvement Stakeholder management - Critical for driving compliance across organization

Beneficial Skills

Project management capabilities Risk assessment methodologies Clinical research operations understanding

Unique Aspects

High focus on first-time quality and inspection readiness indicates sophisticated quality management approach
Significant emphasis on root cause analysis and CAPA processes suggests mature quality system
Integration of quality metrics and KPIs shows data-driven approach to compliance

Career Growth

2-4 years in role typically required before advancement to director-level positions

Potential Next Roles

Quality Assurance Director Clinical Operations Director Regulatory Affairs Manager Global Compliance Manager

Company Overview

Alimentiv

Alimentiv is a specialized clinical research organization focusing on clinical trials and research services

Mid-sized player in the clinical research sector with strong focus on quality and compliance
Significant presence in Canadian healthcare research market with international operations
Professional environment with emphasis on regulatory compliance and quality excellence
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  • Salary estimates and market demand analysis
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  • Critical success factors and key skills
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