PSI CRO AG

Data Manager – Clinical Trials

PSI CRO AG

full-time

Posted on:

Location Type: Remote

Location: Brazil

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Tech Stack

Oracle

About the role

  • Track database set-up, testing, maintenance and data entry
  • Communicate with clients, project teams and vendors on data management matters
  • Review study documents, design and develop project specific guidelines and instructions
  • Design eCRF, Data Management and Data Validation Plans and test EDC databases
  • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
  • Code medical data
  • Track and report metrics leading to database lock
  • Coordinate the processing, dispatch and archiving of CRFs/queries
  • Maintain Clinical Data Management working files
  • Perform database QC checks, prepare and attend audits
  • Train site staff and project teams on CRF completion and data management topics

Requirements

  • College/University degree (Life Science, Pharmacy degree is a plus)
  • Demonstrated experience of managing clinical or medical data
  • Full working proficiency in English
  • Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
  • Proficiency in MS Office applications
  • Organisational and time management skills
  • Ability to work independently and multi-task
Benefits
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementdatabase set-updata entryeCRF designdata validation plansmedical data codingdatabase QC checksCRF completionSAE reconciliation
Soft Skills
communicationorganizational skillstime managementindependencemulti-tasking