Clinical Research Associate Manager

Novartis Farmacéutica; Montreal; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate (CRA) Manager to lead and develop a team of CRAs. This pivotal role involves fostering a collaborative culture, ensuring compliance with the highest standards in clinical research, and managing performance effectively. The ideal candidate will possess strong leadership skills, a deep understanding of international drug development processes, and the ability to coach and influence others. This position offers an exciting opportunity to make a significant impact in a dynamic environment dedicated to improving patient outcomes.

Qualifications

• Minimum 7 years’ experience in clinical research and team leadership.
• Thorough understanding of drug development processes and regulations.

Responsibilities

• Manage CRA team performance and ensure compliance with monitoring activities.
• Support recruitment strategies and promote a culture of quality.

Skills

Leadership

Change Management

Clinical Research

Communication Skills

Project Management

Fluency in English

Fluency in French

Job description

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 for the further development of CRAs into the site manager role. The CRA manager plays a crucial role in creating a collaborative culture to implement new ways of working and delivering quality in a multiple therapeutic area environment. The CRA Manager will be responsible for management of internal CRAs as well as working closely with Monitoring Services Oversight Manager to ensure the appropriate workload distribution and assignment for all CRAs while ensuring efficiency KPIs.

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

About the Role

Key responsibilities:

• Supporting recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
• Being accountable for monitoring quality, timely data entry and issue resolution
• Ensuring CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes
• Promoting a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• Actively managing CRA team performance including implementation of development and performance improvement plans

What you’ll bring to the role:

• Excellent coaching capability to best support CRA in driving right mindset and behavior
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, risk-based monitoring and Novartis standards
• Good communication skills, ability to influence others & relationship management
• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials as well as experience in project management and evidence of team leadership capabilities
• Ability to travel domestically for on site oversight visits
• Fluent in both written and spoken English & French

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

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