Expert Clinical Research Associate

hace 3 semanas

Buenos Aires, Argentina Novartis A tiempo completo

387878BR

**Expert Clinical Research Associate**:
Argentina

**About the role**

**Work Model**:Hybrid

**Locality**:Buenos Aires

**About the Role**:
Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and
remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD
trials within the country in adherence with monitoring procedures and processes in accordance with
ICH/GCP, local regulations and SOPs. Proactive site performance management (recruitment &
quality) and early identification of real site needs and issues as the single best point of contact
(internally & externally) for all sites (from issue management to risk identification)

**Key responsibilities**:
Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis
expectation on milestone and deliverables with true ownership mindset
- Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan

and Novartis procedures
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.

Performs continuous training for amendments and new site personnel as required. Re-trains site
personnel as appropriate
- Conducts continuous site monitoring activities (onsite and remote). Implements site management

activities to ensure compliance with protocol, ICH/GCP, global and local regulation including
Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
Documentation according to GDP and Novartis standards.
- Identifies deficiencies in site processes and monitor site processes performed outside the site,

works in close collaboration with site on risks mitigation and process improvements
- Promotes a compliance culture advocating adherence to highest standards and ethical integrity,
- Establish a strong partnership and true collaboration with the site, to increase patient density and

decrease issues at site.

**Commitment to Diversity & Inclusion**:

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

**Role Requirements**

**Essential Requirements**

**Education**:

- Degree in scientific or healthcare discipline

Languages: Fluent in both written and spoken English and Spanish language
Experience/Professional
- Minimum 4 years pharmaceutical industry experience

in all aspects of monitoring and site management
- Field monitoring experience is desirable

**You’ll receive**:Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.

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

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Buenos Aires

**Company/Legal Entity**

Novartis Argentina S.A

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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