Cra Manager

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as CRA Manager
Your Responsibilities:

- Actively manage CRA team performance including implementation of development and performance improvement plans. Supports implementation of Risk Based Monitoring in GCO clinical trials by coaching and training CRAs on process thinking, risk-based monitoring concept and related systems
- Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies. Collaborates with CPM for monitoring trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs. Collaborates with MSOM for country resource strategy
- Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements. Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues
- Manages CRA adherence/compliance to SOPs and required training curricula. Is responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials. Performs ongoing assessment and allocation of monitoring resources within countries to ensure balanced CRA workload for quality monitoring
- Ensures CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements. Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy and budget

Activities & Interfaces How does this role operate within, interact with and impact the organization?
- Interfaces with regional SSO Clinical Program Managers to receive information and give feedback regarding ongoing trial programs. Partners with other Clinical Research Associate Managers within a country to establish communication pathways for best practice sharing and ongoing issue resolution strategies.
- Partners with SSO Study Start-up Managers within the countries to communicate timelines and plan for seamless transitions across teams.

Following capabilities are very important to be able to coach CRA adequately:

- Fast change adaptability to best partner & influencing with sites on fast changing landscape. Trust and rapport building is a very important skill needed for CRA. Good communication, ability to influence others & Relationship management

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

Experience/Professional requirement:

- A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)
- Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
- Experience in project management and evidence of team leadership capabilities
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
- Decision making capability. Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
- 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

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Australia

**Work Location**

Sydney

**Company/Legal Entity**

AU Pharma Pty Ltd

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Temporary

**Shift Work**

No

**Early Talent**

No