Clinical Research Associate –Multiple Positions at CRA, Senior&Expert
Sandoz Canada
Bucharest, Romania
2 zile în urmă

Job Description

Novartis’s Global Drug Development (GDD) organization oversees all drug development activities for its Innovative Medicines division (Pharmaceuticals and Oncology) and the Sandoz division’s biosimilar portfolio.

GDD works collaboratively with the Novartis Institutes of Biomedical Research (NIBR) and Novartis’ customer facing business units to execute the company’s overall research and development strategy.

GDD represents approximately 11,000 associates worldwide.

To continue to add even greater value for the business, we need to have the right people with the right capabilities in the right location.

We need to be customer-oriented and focus on bringing the best services and solutions to the business both globally and locally to support our patients.

Novartis GDD offers an extraordinary work experience with a real opportunity to develop in a highly fast-paced technology-

driven environment where collaboration and innovation are at the heart of who we are and what we do.

Novartis are recruiting for Clinical Research Associates (CRA’s) at varying levels of experience.

We are interested in hearing about your experience and where you believe you could add value in a cutting edge, fast paced and rewarding environment.

As a CRA in Global Drug Development (GDD), you will perform 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. You will be responsible to deliver data within timelines and required quality standards.

You will also be responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

Major Accountabilities :

Your responsibilities and accountabilities will be diverse and aligned to your level of experience. Potential areas of focus : -

  • Trial Monitoring Strategy
  • Allocation, initiation and conduct of trials
  • Delivery of quality data and compliance to quality standards
  • Budget and Productivity
  • Education :

  • Degree in scientific or healthcare discipline or equivalent.
  • Languages :

  • Fluent in both written and spoken English, local language as needed in clusters / countries.
  • Experience / Professional Requirement :

  • Minimum of 2 years’+ pharmaceutical industry experience particularly relating to clinical monitoring or other relevant experience.
  • For Higher Level Positions, candidates will be required to demonstrate greater experience.

    Competencies :

  • Excellent knowledge of drug development process specifically clinical trials / research / site management.
  • Solid understanding of international standards (GCP / ICH, FDA, EMEA).
  • Monitoring experience is desirable and essential for higher levels.
  • Understanding of project management methodologies desirable.
  • Skills & Knowledge :

  • Ability to travel; a minimum of 50% overnight travel may be required.
  • Strong communication skills, ability to influence others.
  • Excellent communicator and presenter (oral and written), ability to communicate to Senior Leaders / Stakeholders internally and externally.
  • Ability to manage sites independently. Proven ability to work independently with minimal supervision.
  • Strong 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.
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