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FortreaPosted 1 month ago

Project Coordinator I

On-siteSão Paulo, São Paulo, Brazil

Full TimeLarge

Job Summary

Set up and maintain project schedules using MS Project, CTMS, and governance tools while escalating timeline risks. Assist with timesheet versus budget reviews, vendor financial tracking, and contract reconciliations. Conduct contract versus study plan reviews, manage out-of-scope work, and create change order forms. Update the Xcellerate Risk Identification and Issue Resolution tool, ensure risk assessment categorization is complete, and track protocol deviations. Prepare for audits by creating storyboards to document potential issues and support timely closure of CAPAs. Facilitate study team communication through meetings, ADI logs, and task order matrices. Collaborate on TMF uploading and reviews, enforce subject identifier redaction, and maintain lessons learned trackers. This role supports Project Leads within the Project Management Academy, a continuous learning environment for developing clinical project management leaders.

Required Qualifications

  • University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from appropriately accredited institution
  • three (3) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting
  • relevant and equivalent experience in lieu of educational requirements
  • 0-2 years of relevant industry experience
  • Must be able to work at a computer keyboard 6-8 hours per day
  • Must be flexible to accept changes in work assignments, as business needs require

Desired Qualifications

  • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs

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