Clinical Data Manager – Hungary

Excelya>All job opportunites>Full-time, Permanent Contract>Clinical Data Manager – Hungary

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

General Responsibilities/Tasks:

Set-up:

  • Protocol Review eCRF set-up, UAT plan execution, Safety notification & safety reconciliation tools (SAGA/SARA) implementation (specifications & testing).
  • Study plan/documents development/review: Data Management Plan, Data validation. Specifications, eCRF completion instructions, validation listing & reports specifications (CMS), communication plan, training slides kit for CRA and investigators, File transfer specifications (IRT, eCOA, Central lab), Centralized Monitoring Plan(CMP).
  • Organize and conduct appropriate meetings with study team (Data Strategy Collection meeting, CMP meeting).
  • Interact with vendors (IRT, eCOA, Central Lab, Biomarkers …) for external data collection.

Study conduct/Closure:

  • Data validation, Safety reconciliation.
  • Data review including protocol deviation.
  • Manage external data loading and reconciliation (IRT, eCOA, Lab, Biomarkers…).
  • Organize and conduct appropriate data review meetings (including protocol deviations) for DMC, IA, Database lock.
  • Database lock /eTMF archiving.Coordination and oversight of Service Provider deliverables execution for outsourced DM studies or functional services.
  • Provide support to transversal business activities as needed.

Minimum Requirements :

  • Master’s Degree in a relative field is considered as a plus.
  • At least 2-3 years of experience in clinical research.
  • Experience with Phase I or II in Immunology & Inflammation, Neurology or Rare Disease.
  • Fluency in English and in local language.
  • Medidata knowledge is a plus.

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