Associate Data Project Manager
Bucharest, Romania
6 zile în urmă

Job Overview : Responsibilities :

Responsibilities :

  • To assist the internal Project Team to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing;
  • to develop and implement project plans and technical specifications for relevant Data Management tasks in project scope, to document any changes to the Data Management project plans and communicate to the Project Team

  • Provide input, assistance and / or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification, support the Project Data Manager performing the user acceptance testing (UAT) during the initial EDC setup, database migrations and study relevant supporting systems, assist with and / or oversee the creation of test data for entry screens and edit checks, manage EDC access request and documentation
  • Maintenance of the study specific documentation including the TMF requirements, prepare and update of study reports and metrics as required, participate in the SAE reconciliation process and follow up with the internal / external teams
  • Coordinate the study team training assignments via respective internal training system, maintain list of SOPs implemented on project, if applicable, to support the Project Manager with the coordination and the implementation of the study portal and dashboard, as applicable
  • Participate / attend Sponsor meetings as required
  • Participate in and / or contribute to Sponsor and / or Regulatory audits / inspections, assist in the response to internal audits and Corrective Action Plan Agreement (CAPA) resolutions, as applicable
  • Perform other duties as required by the Department, provide guidance and training to Level 1,2 and new hires into the CDA / EDS role
  • Education / Qualifications :

    Education :

  • University degree in Medical / Life Science / Biological science or a related discipline in the science / healthcare field or equivalent education
  • Experience : Experience :

    Experience :

  • Minimum 2+ years of CDM experience or Biostatistics in a CRO or pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
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