Senior Data Manager
Alira Health
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description Summary The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspectiveJob DescriptionROLEThe Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sourcesThe Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.KEY RESPONSABILITIES Accountable for driving achievements of project milestones from study start up through to delivery of databaseProvide Data Management input into the protocolDesign the Case Record Form and guide process for CRF approvalDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study teamValidation of the database and computerized checks, including SAS listings or SAS checksValidation of the database and computerized checks, including SAS listings or SAS checksFor EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRFFor EDC studies timely response to issues identified by the eCRF HelpdeskPrepare CRF completion guidelinesPrepare study specific data-entry guidelines and train data-entry staffPerform term coding for clinical studies, raise manual queries for uncoded terms as requiredQuery management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings
Verona
Wed, 18 Sep 2024 07:04:53 GMT
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