Data Management Specialist

Há 2 dias

Buenos Aires, Brasil beBeeClinical Tempo inteiro US$81.417 - US$114.809
Clinical Data Manager

Job Summary:

  • The Clinical Data Manager II will lead multiple concurrent studies, ensuring data is collected, managed, and reported clearly, accurately, and securely.

Responsibilities Include:

Data Management Lead
  • Monitor study status on an ongoing basis.
  • Presentation of deliverables to clients, gathering feedback, and proposing solutions.
  • Provide regular data status reports to the project team.
  • Oversee the work of the Clinical Data Coordinator as required (quality, timeliness).
  • Oversee vendors to ensure timelines and deliverables meet sponsor and protocol requirements.
  • Conduct reconciliation between external data and data in the EDC system to ensure consistency.
Study Setup – Technical
  • Develop the data management plan.
  • Build a study-specific clinical database using the EDC system.
  • Design the electronic case report form (eCRF).
  • Coordinate the validation and testing (UAT) of the clinical database.
  • Support the study team with the development of external systems capturing clinical data.
User Training and Support
  • Develop eCRF completion guidelines and other training material.
  • 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.
  • 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.

Requirements:

  • Bachelor’s or Master’s degree in a related field of study.
  • 10 years of clinical data management experience in the pharmaceutical industry or in a CRO environment.
  • 5 years of experience as a lead data manager.
  • Extensive experience working with EDC systems (experience with Medrio and Medidata Rave preferred).

Essential Skills:

  • Highly organized and detail-oriented.
  • Project planning and time management skills.
  • Strong verbal and written communication skills.
  • Understanding of the drug development process and of applicable regulations.
  • Good understanding of CDISC SDTM/CDASH standards.

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