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Senior Data Manager

Company Name:
Koch Davis
Serving as project data manager for large projects or multiple smaller projects providing data management expertise, timelines for DM deliverables and driving DM activities to ensure timely deliverables within quality standards and approve budget, consistency of data for all trials within same project. Critically review protocol to ensure that it clearly and accurately describes data points/time points collected in the CRF. Drive CRF/ eCRF and other data collection tools development, gather content and integration requirements for CRF/ eCRF and other data collection tools based on clinical trial protocol and management of data interchanges with internal and external partners by establishing data transfer agreements and adherence to industry standards. Establish expectations for dataset content and structure including a CRF development. Contribute to global standardization of data management and database programming processes and process improvement and efficiency. Implement thorough and efficient user acceptance testing processes across clinical trial databases. Develop data management plans and quality management plans that will deliver accurate timely consistent and quality clinical data. Continuous liaison between internal and external partners to establish, align and confirm data management expectations for assigned trial. Lead data conversion process from mapping of variables from non CDISC data standards to CDISC SDTM annotations in collaboration with programming. Track and report status and progress of data management for allocated trials and being proactive in assurance of smooth and successful timely locking of databases. Identify and communicate lessons learned, best practices and frequently asked questions at trial level. Present and provide training at investigator and monitor meetings. Coach, train and mentor of data management colleagues.
Requirements
10+ years of data management experience in pharmaceutical industry (Sponsor or CRO). Project and team leadership experience. In depth knowledge of the clinical trial process, database programming, clinical operations, quality management and systems applications. Global and cross functional collaboration experience. Expertise in current pharmaceutical industry standards (i.e. CDISC, SDTM , CDASH , etc.). Proficiency in SQL and SAS programming. Proficiency in medical coding; knowledge of medical coding tools and dictionaries. Thorough knowledge of electronic data captures (EDC) systems.
Education
Master degree in life sciences, computer science or mathematics.
Client
This multinational pharmaceutical corporation develops and produces medicines and vaccines for a wide range of medical disciplines.


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