Clinical Data Manager

Há 3 dias

São José dos Pinhais, Paraná, Brasil beBeeDataGovernance Tempo inteiro R$900.000 - R$1.200.000
Job Title: Data Governance Specialist

As a key player in our organization, you will ensure that data captured in multiple clinical trials is collected, managed, and reported clearly, accurately, and securely.

Responsibilities
  • Monitor study status on an ongoing basis
  • Present deliverables to stakeholders, gather feedback, and propose solutions.
  • Provide regular data status reports to the project team
  • Oversee work of the Clinical Data Coordinator as required (quality, timeliness)
  • Oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements
  • Be responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close.
  • Conduct reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with safety databases for adverse events/SAE data
Study Setup - Technical
  • Develop a comprehensive data management plan (DMP)
  • Build a study-specific clinical database using the EDC system: Design the electronic case report form (eCRF)
  • Coordinate validation and testing (UAT) of the clinical database
  • Support the study team with the development of external systems capturing clinical data (ePRO or IWRS), ensuring that any data transfer requirements between these systems and the EDC are documented and tested appropriately.
User Training and Support
  • Develop eCRF completion guidelines and other training materials
  • Conducts training for site users/monitors on the clinical database
  • Activate/de-activate new users in the clinical database in response to requests from the project manager and maintain records of such requests
  • Respond to users requiring assistance with the EDC system
Database Close/Lock
  • Generate data listings and reports needed for data review in preparation for database close/lock
  • Ensure that data management documentation is complete and up to date in the trial master file (TMF)
  • Archive the clinical database and related documents

Required skills and qualifications include experience working with clinical data, knowledge of electronic data capture (EDC) systems, and excellent communication skills. Benefits include a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. Others include working collaboratively as part of a team, managing competing priorities, and staying up-to-date with industry developments.

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