Lead Data Manager

6 giorni fa

Milano, Lombardia, Italia PSI CRO A tempo pieno
Job Description

The Lead Data Manager will be responsible for overseeing all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium-sized projects.

Key Responsibilities
  • Communication: The Lead Data Manager will serve as the primary point of contact for project teams and company departments regarding clinical data management, as well as the communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting.
  • Data Management: The Lead Data Manager will coordinate data management activities within clinical projects, including EDC development, data collection, cleaning, reconciliation, database lock, and the development of final integrated databases and data management deliverables.
  • Database Management: The Lead Data Manager will be responsible for the development of data validation plans, the creation of edit check specifications, data entry coordination and supervision, data validation, and the resolution of data discrepancies/deficiencies.
  • Document Management: The Lead Data Manager will liaise with the Document Center regarding the maintenance of the Trial Master File (TMF) and electronic TMF (eTMF).
  • Quality Control: The Lead Data Manager will perform database QC checks and document the results. They will also participate in internal and client/third-party audits/inspections of Data Management and follow up on and resolve audit findings related to Data Management.
Requirements
  • A college or university degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities.
  • At least 3 years of experience in full scope data management responsibilities in international EDC studies.
  • At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable).
  • Project data management experience is a plus.
  • Full working proficiency in English.
  • Organizational and managerial skills.

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