Clinical Data Manager Coordinator

1 settimana fa

Milano, Italia Jefferson Wells A tempo pieno

Role Description We are looking for a Data Management Coordinator to manage, coordinate, and organize the activities of our Client's Data Management staff. The candidate will collaborate with cross-functional teams, including Clinical Operations, Biostatisticians, Medical Affairs, and Project Managers. The candidate should have excellent knowledge of regulations and reference standards, as well as major medical dictionaries such as MedDRA, WHO-DD, etc. Key Responsibilities Manage, coordinate, and supervise data management activities on clinical studies and investigations (drugs, nutraceuticals, medical devices, IVDs, etc.); Coordinate and supervise the design, configuration, and maintenance of clinical databases and electronic CRF; Coordinate and supervise the drafting and review of data management documentation (e.g., Data Management Plan, Data Validation Plan); Coordinate and supervise data cleaning and query management activities in compliance with study timelines and quality standards; Coordinate and supervise clinical data review and reconciliation activities to ensure data integrity; Coordinate and supervise the design and validation of study eCRFs; Follow the coding process for adverse events (AEs), medical history terms, and concomitant medications; Coordinate and supervise database closure and data transfer activities; Supervise and coordinate activities delegated to external CRF service providers; Maintain documentation in compliance with GCP, company procedures, and applicable regulatory requirements; Interact with clients, auditors, and competent authorities for the Data Management Unit's activities; Collaborate with the Business Development Unit in preparing proposals; Participate in client meetings (bid defense, kickoff, etc.) and ensure continuative and proactive collaboration with other business units. Minimum Requirements Scientific degree is preferred (e.g., Biology, Biotechnology, Pharmacy, Statistics, Biomedical Engineering); 10 years of experience as Data Manager; Familiarity with Microsoft Office tools (Excel, Word, etc.); Familiarity with the main EDC systems and the design and validation processes of electronic CRFs; Strong attention to detail and organizational skills; Excellent written and spoken English. #J-18808-Ljbffr

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