Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology.
As a global company, the resources and opportunities for growth and development are plentiful including global and local cross-functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work.
With a strong medicines pipeline, our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
**Your responsibilities**:
Your responsibilities include, but are not limited to:
- Monitors patient data and study-related information related to clinical study sites and clinical trial participation.
Ensures the investigator adheres to research protocols, regulatory requirements, and good clinical practices and provides input into the data validation plan.
Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable.
May monitor study sites and audit facility selection.
- Experienced specialists perform monitoring activities related to initiation, conduct (recruitment, quality data collection), and timely completion of assigned clinical trials.
- Is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP & ICH, local regulations, and SOPs.
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial
- Performs site Initiation Visit, and ensures site personnel is fully trained on all trial-related aspects
- Applies company policies and procedures to resolve a variety of issues.
- Is the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement, and meeting Novarti's expectations on milestones and deliveries.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Distribution of marketing samples (where applicable).
- Work from Home Office, not Home Base.
**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**
**What you'll bring to the role**:
- Complete university degree in health, biological, or related areas.
- Minimum 2 years of experience in clinical monitoring.
- Experience in the therapeutic areas of cardiology, neurology, or oncology will be considered a differential.
- Fluent in Spanish.
- Advanced in English.
**Why consider 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!
**Division**
- Global Drug Development
**Business Unit**
- GDO GDD
**Country**
- Mexico
**Work Location**
- Estado de Mexico
**Company/Legal Entity**
- NOV CORPORATIVO MEX
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No