Clinical Data Manager II

3 semanas atrás

Buenos Aires, Brasil Indero (formerly Innovaderm) Tempo inteiro

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As a Clinical Data Manager II, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely.
This role will be perfect for you if:

  • You want to work on studies end-to-end (involved from protocol review to database lock)
  • You have the experience and confidence to lead multiple concurrent studies successfully as a Data Manager
  • You enjoy working directly with clients and forming recommendations as needed
Responsibilities
Data Management lead
  • Monitor study status (ie. enrollment, CRFs monitored/approved, etc.) on an ongoing basis
  • Present deliverables to clients, 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
  • Is 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 sponsor safety databases for adverse events/SAE (Serious adverse events) data
Study setup – Technical
  • Develop the data management plan (DMP)
  • Build a study-specific clinical database using the EDC system:
  • Design the electronic case report form (eCRF)
  • Build the clinical database in the chosen EDC independently or with the support of an EDC programmer (determined based on the complexity of the system and study.
  • Coordinate the 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

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