Expert Clinical Research Associate
hace 2 semanas
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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