**Job purpose**
The Clinical Site Associate performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. The Clinical Site Associate is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.**Major Accountabilities**
- Trial Monitoring strategy
- Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials Allocation, initiation and conduct of trials
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
- Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
- Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
- Facilitates the preparation and collection of site and country level documents
**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**: Degree in scientific or healthcare discipline.**Languages**: Fluent in both written and spoken English and Spanish, as needed in clusters/countries**Experience**:
- Minimum of 3 years experience in site monitoring
- Excellent knowledge of the drug development process
specifically clinical trial/research- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- Ability to manage multiple priorities and manage time efficiently.
- Basic project management skills to support in
CSM activities.- 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.
- Advanced communication skills, ability to influence others.
- Good strategic thinking: Ability to anticipate potential
issues and take appropriate actions with or without supervision.- Advanced data accuracy: Ability to work focused with a great attention to detail.
- Ability to manage sites independently; Proven ability to work independently with or without mínimal supervision by direct
**If you are a curios person, willing to help us to innovate and re-imagine medicine this is he opportunity your are looking for!!**
**Division**
- Integral Drug Development
**Business Unit**
- GDO GDD
**Country**
- Spain
**Work Location**
- Madrid
**Company/Legal Entity**
- Novartis Farmacéutica, S.A.
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No