Clinical Research Associate

hace 1 semana

Buenos Aires, Argentina Novartis A tiempo completo

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have #GCO
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).

**Your responsibilities include, but are not limited to**:

- 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.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
- Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality
- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
- Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
- Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date

**What you’ll bring to the role**:
Fast change adaptability to best partner & influencing with sites on fast changing landscape
- Trust and rapport building is a very important skill needed
- Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
- A minimum of 50% overnight travel may be required
- Good communication skills, ability to influence others & Relationship management
- Excellent communicator and presenter (oral and written)
- Ability to manage sites independently; Proven ability to work independently with mínimal supervision
- Good analytical thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision
- Digital & tech capabilities, including computer skills (Microsoft platforms)

**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**

**Required Experience & Qualifications**:
**Education**:

- Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience).

Languages:

- Fluent in both written and spoken English and country language

Experience/Professional requirement:

- 2 years pharmaceutical industry experience or other relevant experience
- Central/in-house monitoring or field monitoring experience is desirable

**#GCO**

**Why Novartis?**

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis

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

**Division**

Global Drug Development

**Business Unit**

GCO

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