Clinical Research Associate Manager

Healthcare Businesswomen’s Association; Montreal; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking organization as a Clinical Research Associate (CRA) Manager, where you will lead a dynamic team in enhancing site management and fostering a culture of compliance. This role emphasizes strong leadership and change management skills, ensuring quality across various therapeutic areas. You will be instrumental in developing CRAs into effective site managers, implementing innovative working methods, and maintaining high standards in clinical research. If you are passionate about driving excellence in clinical trials and have a proven track record in the field, this is the perfect opportunity for you.

Qualifications

• Minimum 7 years’ experience in clinical research with demonstrated team leadership.
• Thorough understanding of international drug development standards and regulations.

Responsibilities

• Manage CRA team performance and development.
• Ensure high-quality, compliant monitoring activities.

Skills

Leadership skills

Coaching capabilities

Clinical Research

Clinical Trials Monitoring

Change Management

Communication

Project Management

Data Analysis

Decision Making

Drug Development

Job description

Job Description Summary

Location: Montreal/Toronto, LI#Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the role:

We are seeking a Clinical Research Associate (CRA) Manager with strong leadership and change management skills to develop CRAs into site managers. The CRA Manager will foster a collaborative culture, implement new working methods, and ensure quality across multiple therapeutic areas. Responsibilities include managing internal CRAs and collaborating with the Monitoring Services Oversight Manager to balance workload and meet efficiency KPIs.

This role reports to the Study and Site Operations (SSO) Country Head, Canada, and works directly with the Monitoring Services Oversight Manager, Portfolio Team Lead, and Study Start-up Team Lead.

Key responsibilities:

1. Supporting recruitment strategies and site performance by ensuring high-quality, compliant monitoring activities.
2. Being accountable for monitoring quality, timely data entry, and issue resolution.
3. Identifying and addressing CRA monitoring competency gaps through targeted training and co-monitoring visits.
4. Promoting a culture of compliance, integrity, and human subject protection to ensure reliable trial results.
5. Managing CRA team performance, including development and performance improvement plans.

What you’ll bring to the role:

Essential:

1. Leadership skills
2. Excellent coaching capabilities to support CRA development and foster the right mindset and behaviors
3. Thorough understanding of international drug development standards (GCP/ICH), health authorities (FDA/EMA), local regulations, risk-based monitoring, and Novartis standards
4. Strong communication skills, influencing ability, and relationship management
5. Minimum 7 years’ experience in clinical research, including trial monitoring, planning, and project management, with demonstrated team leadership
6. Ability to travel domestically for site oversight

Desirable:

• Fluency in English and French, both written and spoken

Skills: Bilingual (French/English), Change Management, Clinical Research, Clinical Trials Monitoring, Coaching, Collaboration, Communication, Data Analysis, Decision Making, Drug Development, FDA Regulations, ICH GCP Guidelines, Leadership, Project Management, Team Leadership