摘要
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:
Essential:
- Leadership skills
- 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
Desirable:
- 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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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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
