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Clinical Data Reviewer

Role overview

Qualifications

  • Bachelor's degree
  • At least 1 year of experience in the Clinical Research Industry
  • Clinical Monitoring experience is an advantage
  • English proficiency at CEFR B2 level or above

Responsibilities

  • Review clinical data remotely and identify errors, systemic issues and trends related to data integrity, participant safety and site performance
  • Generate, follow up and resolve data queries and site issues, and identify potential protocol deviations
  • Develop and maintain study-specific Central Data Review tools, templates and tracking materials
  • Support the setup and management of risk-based and central monitoring tools and activities

Key facts

  • Remote from: Brazil
  • Full time
  • Junior (1-2 years)
  • English

Other skills

  • Microsoft Office
  • Analytical Thinking
  • Detail Oriented
  • Teamwork

About the company

PSI CRO AG  logo

PSI CRO AG

Contract Research Organizations (CRO)

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size1001 - 5000

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Job description

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 3000 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 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 clinical data remotely and identify errors, systemic issues and trends related to data integrity, participant safety and site performance
  • Generate, follow up and resolve data queries and site issues, and identify potential protocol deviations
  • Develop and maintain study-specific Central Data Review tools, templates and tracking materials
  • Support the setup and management of risk-based and central monitoring tools and activities
  • Assist with central monitoring signal review, root cause investigation and follow-up
  • Support the Central Monitoring Manager with study data, documents and reports
  • Contribute to inspection readiness, including eTMF QC and study archive activities

Qualifications

  • Bachelor’s degree
  • At least 1 year of experience in the Clinical Research Industry
  • Clinical Monitoring experience is an advantage
  • English proficiency at CEFR B2 level or above
  • Proficiency in MS Office applications
  • Analytical mindset and attention to detail
  • Ability to learn, plan and work effectively in a dynamic team environment

Additional Information

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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