Clinical Data Associate (level dependent on experience)
CTI
Lisbon, Portugal
há 3 dias

Job Purpose

Summary Facilitate the review and cleaning of clinical data associated with clinical research studies while assuring the integrity of the data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

What You'll Do

  • Review and issue queries for CRF data, based on automated edit checks, manual review, post-hoc data listings, and sponsor requirements
  • Perform user acceptance testing of Clinical Study databases
  • Ensure the accuracy of clinical databases as compared to the CRF and the result of any data queries
  • Prepare study specific status reports
  • Assist with the set-up of data management study files and the collection, transfer and archiving of study documentation and controlled documents
  • Maintain all the necessary documentation to support accuracy and integrity of clinical databases
  • Perform all duties according to CTI Standard Operating Procedures (SOP’s) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP) / ICH guidelines
  • Maintain accurate records of all work performed
  • What You Bring

  • 0-2 years scientific research experience in any capacity
  • Bachelor’s degree or equivalent in biological, behavioral, computer science; or 2 years clinical research experience
  • Experience with Oracle Clinical, Medidata, OmniComm TrialMaster, and IBM Clinical Development
  • Experience providing knowledge of ICH / GCP guidelines and applicable regulatory requirements
  • Why CTI?

  • We support career progression 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
  • We value education and training We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
  • We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
  • Our culture is unparalleled Click here to learn more about The CTI Way
  • We think globally and act locally We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our CTI Cares program)
  • We are looking toward the future We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
  • Our work makes a difference We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
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