Clinical Data Manager

Jefferson Wells is looking for a Data Management Manager (Biometrics and Data Sciences Department -BDS), on behalf of Italfarmaco (Cinisello Balsamo HQ). Key Responsibilities: Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects (phase I to phase IV). Efficiently plans, coordinates and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects. Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members. Acts as a driver to set program level data collection and reviews standards with cross functional team. Provides strong quality and project oversight over third party vendor responsible for data management deliverables. Takes a leadership role to gather content and integration requirements for EDC in close collaboration with partners supporting different data collection systems (eCOA, External Data, etc). Enforces data standard conventions and quality expectations for clinical data per defined processes. Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, Data Transfer Specifications, eCRF Completion Guidelines and other study documents to ensure quality and standardization. Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness. Represents DM on cross-functional project teams. Support the Health Authority inspections, audits, and CAPA implementation. Provides coaching and quality oversight of junior Data Managers/consultants. Acts as a functional representative and a point of contact for CRO and preferred vendors. Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. J-18808-Ljbffr

Location: provincia-di-milano, IT

Posted Date: 2/12/2025