Clinical Data Coordinator III

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POST DATE 9/9/2016
END DATE 10/23/2016

MedImmune, LLC Mountain View, CA

Mountain View, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Operating in FDA regulated environment, the em strong Clinical Data Coordinator III /strong /em will manage Translational Sciences Biorepository (TSB) study lifecycle activities for assigned studies across Therapeutic Areas: br ul li  Create, review and maintain study related documents including specimen plans and data specifications /li li  Work closely with study team personnel including: Clinical Operations, Clinical Data Management, Translational Science, and External Laboratory vendors. Represent Translational Science Biorepository at study related team meetings /li li  Execute routine and non-routine data entry/upload into LIMS database, review and perform edit checks. Run edit checks to identify missing, ambiguous, or illogical data. Issue queries to sites, central laboratories, monitoring CROs, and/or Clinical Operations, and apply corrections/updates to database as identified through query resolution, data review, etc. /li li  Provide test, header and production data to internal/external stakeholders. Generates study reports/metrics for data cleaning and complex reconciliations between multiple data sources /li li  Coordinate specimen and data delivery timelines for TSB /li li  Manage specimen requests, evaluate available inventory and assign usage /li li  Monitor Central Lab compliance with Translational Science Biorepository standards and escalate issues as necessary /li /ul p /p ul li  Actively participate in TSB continuous process and quality improvements. As Subject Matter Expert, train new staff and guide peers in areas of specific expertise. /li li  With sound understanding of CS&DM internal practices and policies, independently problem solve and strategize to resolve issues to ensure study timelines and objectives are met /li li  Position and management of systems is complex and errors in judgment would have a serious impact on the organization /li li  Independently provides solutions to a variety of problems of difficult scope and complexity /li li  Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules /li li  Ability to work independently and collaboratively with sound judgment in cross functional teams /li li  Operates autonomously with infrequent managerial input /li /ul p /p