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Clinical Compliance Specialist - Job Opportunity at Alimentiv

Saskatoon, Canada
Full-time
Senior
Posted: April 19, 2025
On-site
CAD 76,000-127,000 per year

Benefits

Regulated clinical research environment exposure
Professional development opportunities
Work with cutting-edge clinical trials
Healthcare industry experience

Key Responsibilities

Lead quality issue management and root cause analysis for clinical trials
Conduct site audits and maintain inspection readiness
Oversee training compliance and documentation
Drive continuous improvement in quality management systems
Provide regulatory compliance expertise and guidance

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 and critical thinking abilities Quality by Design principles knowledge
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Sauge AI Market Intelligence

Industry Trends

Clinical research compliance requirements are becoming increasingly complex with evolving global regulations and data privacy standards Growing emphasis on risk-based quality management systems in clinical trials Increasing adoption of digital tools and remote monitoring capabilities in clinical research

Salary Evaluation

The offered salary range is competitive for the Canadian market, reflecting the senior nature and specialized expertise required. Similar roles in major pharmaceutical hubs like Toronto or Montreal might command 10-15% higher compensation

Role Significance

Typically works within a quality assurance team of 5-10 specialists, collaborating with multiple clinical study teams
Senior individual contributor role with significant influence on organizational risk management and quality assurance

Key Projects

Implementation of quality management systems Regulatory inspection preparation Clinical trial site audits Quality issue investigation and resolution Process improvement initiatives

Success Factors

Deep understanding of clinical research regulations and ability to interpret evolving requirements Strong stakeholder management skills across multiple organizational levels Proactive risk identification and mitigation approach Balance between compliance requirements and operational efficiency

Market Demand

High demand due to increasing regulatory scrutiny in clinical research and growing emphasis on quality management systems

Important Skills

Critical Skills

Regulatory knowledge of ICH-GCP and ISO standards is fundamental for ensuring compliance Root cause analysis expertise is essential for quality issue resolution Stakeholder management skills are crucial for driving quality initiatives across teams

Beneficial Skills

Project management capabilities enhance effectiveness in coordinating quality initiatives Knowledge of emerging clinical research technologies aids in modernizing quality processes Understanding of risk-based monitoring approaches supports efficient resource allocation

Unique Aspects

Focus on first-time quality in clinical research execution
Direct involvement in shaping quality management systems
Blend of technical compliance expertise with strategic quality management

Career Growth

2-4 years in role before advancement, depending on organizational growth and project success

Potential Next Roles

Quality Assurance Manager Clinical Operations Director Regulatory Affairs Director 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 organization (CRO) space with specific expertise in certain therapeutic areas
Significant presence in Canadian healthcare research market with potential for international exposure
Professional environment with emphasis on quality and compliance, typical of regulated healthcare research organizations
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