Clinical Research Associate Manager

3 days ago

Montréal, Canada Novartis Full time

**Summary**:
Location: Montreal/Toronto, LI#Hybrid

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
- 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

Division

Development

Business Unit

Innovative Medicines

Location

Canada

Site

Montreal

Company / Legal Entity

CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

Alternative Location 1

Toronto, Canada

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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