北京博智盛德企业管理咨询有限公司<br>大型外资医药公司Study Data Manager<br>
Performing Study Data Management tasks<br>? Manage Study Data Management Teams efficiently and consistently for all assigned regional studies<br>? Assume operational responsibility as Study Data Manager for all assigned regional studies <br>? Manage regional study sites in global EDC studies where assigned<br>? Document all activities adequately within the sub-function for all assigned studies according to SOPs, i.e. maintain the electronic Study Data Management Book<br>? Incorporate and maintain Global/Therapeutic Area /Project standards in clinical studies, request standard enhancements. This includes CRFs, database structures, data derivation rules, codelists and edit checks. <br>? Specify and / or develop study specific data components (study metadata), interact with the EDC developer in the specification and design of eCRFs and database structures<br>? Specify study specific data consistency checks (edit checks) in the Data Validation Document and communicate within the study team, coordinate and check the implementation.<br>? Contribute to the DM part of the study package test and EDC UAT test.<br>? Perform consistency check for external data (internal consistency and consistency with other data)<br>? Request and coordinate the SAS- programming of edit checks and derivations, request and coordinate the programming and execution of transformation programs from original data to analysis database using SAS. <br>? Identify and issue queries, incorporate query replies, track query status, apply permissible clarifications using the EDC system and related systems<br>? Contribute to the preparation of data monitoring plans (coordinate amongst Study Teams, Global Medical Surveillance, Drug Safety Monitoring Boards, Authorities and Ethics Committees) (if applicable) <br>? Prepare data listings or data extracts for medical reviews and reports specifically, prepare SAE-reconciliation report and provide to Medical Expert, issue resulting medical queries, provide code review listing to Medical expert, and if applicable update the database.<br>? Complete study specific coding related tasks (handling of coding requests, handling of coding macro, provision of data to Coding, retrieval of data from Coding) Generate queries for coding related issues.<br>? Provide the protocol deviation document for all assigned studies in cooperation with the study team in a timely fashion<br>? Prepare, conduct, and complete the Blind Validity Review Meeting <br>? Prepare a database closure plan, communicate plan within the study team, conduct the database-closure activities<br>? Cooperate with Global DM functions and the study team regarding outsourcing activities in the field of Data Management (e.g. with the Clinical Data Center)<br>? Identification and communication of issues which have the potential to affect timelines or data integrity into study team and Manager, contribute to a transparent benchmarking of Data Management activities for all assigned studies <br>? Train Monitors in all aspects related to a reasonable completion of the CRFs by investigators, train investigators in EDC trials, if applicable<br>? Support Global EDC organization in the resolution of Service Desk tickets for assigned studies<br>? Coordinate with Global EDC all aspects of hardware provisioning in regional EDC trials<br>? Ensure management of high quality clinical data in studies and application of all relevant SOP’s and WP’s as well as Across Project Standard documents (APS)<br>? Apply global clinical data management best practice for all assigned studies</p>
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