Clinical Data Consultant

Mô tả công việc

The Data Sciences and Solutions department within the Clinical Development Organization (CDO) is responsible for global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, data archiving and data standards The Consultant - Process and Technology is responsible for providing technical leadership and process ownership for Data Sciences & Solutions. There are four broad applications/focus areas for this role:Apply broad process/technology knowledge to ensure clinical trial deliverables are consistent and accurateAct as a primary contact within the Data Sciences & Solutions organization for development and support of process and technologyCommunicate and adhere to the global data strategy across the organization as it relates to process and technology. Influence across functions and externally to proactively resolve complex regulatory and business issues related to process and technologyInfluence across functions and externally to proactively resolve complex regulatory and business issues related to process and technology Process/TechnologyStrategy Developmentand Management (75%)Accountable for Defining, delivering, and continuously improving global processes and/or technology to facilitate the reliable planning and execution of deliverablesConsult during the design and execution of clinical trials to ensure the development of the trial is consistent with the global data strategy, as applicable to focus areaProactively identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and enhancements as required across TA/Regions/Functions.Accountable for ensuring process and/or technology interfaces are optimized across CDO Use business case analysis to drive decisions and monitor implementation of CDO initiatives to show return on investmentResponsible for the identification, communication, maturation and adoption of best practices and global standardized business processes, as applicable to focus area.Manage projects/process/technology that span across multiple functions/vendors/other external organizations, areas of focus are InForm/CIS/Central Designer, Clintrial Integrations and CTMM Integrations, Submissions, Integrated Databases, MedDRA/WhoDRUG/SAE in InForm/LSS.Influence internally across functions/team/regions and external organizations (i.e. CDISC, Technology Vendors, TPOs) strategies/products in order to resolve complex technical and business problems facing our global customers.Marry deep phase/TA/geography expertise with deep process and/or technology expertise, as applicable to focus area.Partner and/or strengthen relationships between key providers or customers, including influencing statisticians, statistics COE, physicians, clinical pharmacology and clinical operations etc, as applicable to focus area.Accountable for defining, measuring and achieving group proficiency with new tools/technology, processes, and the application of best practices as applicable to focus area.2. Process Improvement(20%)Continually seek and implement means of improving processes to reduce cycle time and decrease work effort to maximize the return of the investment (i.e. technology purchases, vendor agreements, etc) of the assets managed.Represent Data Sciences’ processes in cross-functional initiativesLead shared learning sessions as appropriate across Data Sciences and Solutions Identify and leads opportunities with partners to increase vendor/partner efficiencies 3. Asset Protection (5%)  Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within Data Sciences and Solutions. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside partiesAccept obligation to Lilly for compliance to the integrity of the company Complete readings of any policy/procedure updates including global medical, Data Sciences and Solutions, and local policies and procedures