Cra Manager

hace 4 semanas

Barcelona, España Novartis A tiempo completo

*Role can be based in Madrid or Barcelona*
Oversight of CRA performance, development and coaching of CRA to drive mindset and behavior
- responsible for managing and addressing CRA performance targets per defined KPIs: delivery, productivity, and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution.
People and resource management - ongoing assessment of allocation of CRAs to studies and sites.
Budget oversight - monitors and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure local targets for travel budget are met.
Ensures CRA monitoring competency gaps are identified and resolved through targeted coaching and training curricula in collaboration with training group.
Liaise on ongoing basis with CPMs to ensure enrollment, data collection and data cleaning are executed by CRAs in a timely manner.
- In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
- Is accountable for monitoring quality, timely data entry and issue resolution
- Ensures 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 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
- 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.

Key Performance Indicators:
1. CRA team performance against trial commitments at the country level, including delivery of trials per defined timelines, number of patients and quality
2. Delivery of high-quality clinical data ensuring adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

**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**

**Education**:

- A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)

Languages:

- Fluent in both written and spoken English

Experience/Professional requirement:

- 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

Competencies:

- 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 standard

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