Clinical Data Reviewer

2 semanas atrás

São Paulo, São Paulo, Brasil PSI CRO AG Tempo inteiro

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

You will join a widespread, yet closely-knit team with the same mentality and desire to develop a smart and intelligent approach to project monitoring. You will help to shape the future of effective risk-based monitoring at PSI and ensure higher quality of study data. You will spend time monitoring study data remotely, identifying errors and issues with site performance.

You will:

  • Review EDC, IxRS, Laboratory, and other vendors' data and clinical listings
  • Identify single errors and systematic issues related to site performance
  • Generate, follow up, and resolve data queries and site issues
  • Identify and record protocol deviations
  • Assist the Central Monitoring Manager with administrative activities, including managing study data, documents, and reports
  • Ensure site monitors receive information on site-related risks & issues. Escalate findings to study teams
  • Assist with root cause investigations and follow-up on site performance signals identified during central monitoring review

Qualifications

  • College/University degree or an equivalent combination of education, training & experience
  • Prior experience in Clinical Research
  • Experience in central monitoring and clinical data review is a plus
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Analytical mindset and attention to detail
  • Ability to learn, plan, and work in a dynamic team environment

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Seniority level
  • Entry level
Employment type
  • Full-time
Job function
  • Administrative
Industries
  • Pharmaceutical Manufacturing
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