Clinical Research Associate Manager

Novartis; Montreal; Hybrid; CAD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate Manager to lead and develop a team of CRAs in a hybrid work environment. This pivotal role emphasizes leadership, compliance, and quality in clinical trials across multiple therapeutic areas. The ideal candidate will possess strong project management skills and a thorough understanding of international drug development standards. Join a passionate community dedicated to improving patient outcomes and be part of a collaborative culture that drives innovation and excellence in clinical research.

Qualifications

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

Responsibilities

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

Skills

Leadership skills

Coaching capability

Communication skills

Project management

Clinical research experience

Knowledge of GCP/ICH standards

Relationship management

Job description

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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 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.

Key Responsibilities

1. Supporting recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
2. Being accountable for monitoring quality, timely data entry and issue resolution
3. 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
4. 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
5. Actively managing CRA team performance including implementation of development and performance improvement plans

Essential Qualifications

1. Leadership skills
2. Excellent coaching capability to support CRA in driving the right mindset and behavior
3. 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
4. Good communication skills, ability to influence others & relationship management
5. 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
6. Ability to travel domestically for on-site oversight visits

Desirable Qualifications

1. 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? Learn more

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Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing