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职位概要 Job Highlights：
职责描述 Key Accountabilities：
– Results achieved versus the PDM task list
– Consistent, high quality project database
– DM deliverables for submission accepted by Quality Assurance (QA), project team, internal audits and authorities
– Timeline adherence
– Feedback from project team members and TDMs
职能需求 Competence Profile：
– Builds effective relationships with CROs/ vendor partners utilized within the project.
– Gives input to the core clinical trial protocol (CTP).
– Defines, reviews and approves key Clinical Data Management Project level deliverables, including: Core Case Report Form (CRF) design, instructions for CRF completion, Project data management plan; e.g database specifications including derivations, edit check specifications, data cleaning plan, Electronic data transmission agreements in accordance with the core protocol , BI, TA Level data standards and Project needs.
– Initiates and compiles PDMAP documentation containing the necessary CDM / Biostatistics & Data Sciences (BDS) documentation for a project together with other members of the trial team as appropriate. Therein ensures appropriate quality, scientific content, organization, clarity, accuracy, format, consistency and compliance with regulatory guidelines.Ensures that SDTM (Study Data Tabulation Model) compliant data is available for analyses together with the Trial Data Manager (TDM) and the SDTM programmer at the CRO (in the context of the BPO).
– The PDM sets up , maintains and validates the project database consistent with the latest industry, BI and project standards. Ensures that the SDTM project database is compliant with the requirements from the project statistical analyses plan and collaborates with the PSTAT, PPROG on a regular basis.
– Establishes conventions and quality expectations for clinical data and plans and tracks the content, format, completeness, quality and timing of the project database via data analytics throughout the conduct of a project.
– Compiles and ensures compliance of all elements of the electronic submission deliverables: (eg.): datasets, trial level SDTM Reviewers Guide and define.xml .
– As part of inspection readiness, the PDM ensures that the TDMAP documentation of the pivotal trials is complete and consistent and communicates with trial data managers during conduct of these trials to set expectations.
– Identifies and communicates lessons learned and best practices at the project level and within CDM. Identifies and participates in DM related process, system, and tool improvement initiatives within CDM.
– Leads / mentors project/trial data managers that support the project in aspects of the data management work.