非公開
■ 職務内容 / Job Description
Responsible to coordinate the Clinical Data Management (CDM) deliverables on assigned clinical projects and may be an expert on CDM processes, standards and technologies, such as EDC and other tools (PV提供用 安全性差分レポートツール, etc.). Member of the Study Team (ST) and the main point of contact for the Data Management (DM) vendor. Responsible to ensure CDM deliverables follow standards and meet data quality. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies with ensuring AIR(always inspection readiness).
Typical Accountabilities
• Coordinate the CDM deliverables on assigned projects depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Communicates and collaborates effectively with all study level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead DM/DM Team Lead working on the study (CRO or in-house).
• Oversight of the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned RIST project(s).
• May provide input to the selection and use of software systems, devices and vendors from the CDM perspective.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
• Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.
• Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM and Japan DO/R&D organization direction, such as contributing the data driven decision making.
ワークライフバランスの良さや、社内(国内外)での豊富なキャリアパスが用意されている点が特徴のグローバル企業です。