New job Clinical Applications Support Specialist in Ridgefield, CT - please send resumes to dan.wienczkowski@rightthinginc.com

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Clinical Applications Support Specialist in Ridgefield, CT - please send resumes to dan.wienczkowski@rightthinginc.com Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Clinical Applications Support Specialist in Ridgefield, CT - please send resumes to dan.wienczkowski@rightthinginc.com "Title: Specialist IV, Clinical Applications Support Location: Ridgefield, CT Duties and Responsibilities: - Ensure the global production environment is 'up & running'. - Assume ownership of problems. Ensure timely and competent support of user community with regard to daily problem solving. - Decide on best problem solution in behalf of the global BDM user community and with minimum supervision. - Work closely with and follow-up with global CAS organization on the resolution. - Initiate and collaborate with Information Technology to solve support- and project-related technical problems. - Use own discretion to chair/drive the necessary changes in business processes. - Develop training package/materials. Ensure training is conducted. - Support user responses to regulatory inquiries. Increased attention and immediate support for distinguished "high priority" trials. - Participation in international software system implementation projects - Participate on International Project Teams, communicate project status. Report the status of the process implementation to the business project manager. - Prepare, coordinate, and supervise system test and implementation of new versions/systems in the Americas Region Validation and Testing according to BI policies as well as FDA and ICH regulations. Ensure hand-over to the CAS or other support unit for productive use. - Provide regular project updates to the global stakeholders, as well as at department meetings and to upper management if requested. - For new processes and system enhancements, determine user requirements together with a user group for a particular business process. Plan and supervise the CAS activities with regard to implementation of a particular process. - Exploring new technology for use in BDM globally Requirements: - Minimum 9 Years with BS, minimum 7 Years, with MS, minimum 4 Years with PhD and 4 or more years experience in the pharmaceutical industry to have a thorough understanding of the business function - Minimum 3 years experience with global clinical application principles in order to apply these principles to user requirements and support system development - Minimum 1 year experience with project management to manage the process implementation and enhancement tasks this position is responsible for. - Professional background in clinical trial reporting. - Excellent knowledge of the business processes for Laboratory Analysis required. Deep expertise in the CARE application (and neighboring applications) are favorable, such as intimate knowledge of or relevant experience with LAB Guideline/Process, LAB, BI Add-on, XLAB, XTRTGEN, XGRAPH, SAS. (2) Professional background in clinical data bases. - Excellent knowledge of the business processes for LAB data loading and External data loading in Oracle LSH (="CDR") required. Deep expertise in the Oracle LSH (and neighboring applications) are favorable, such as intimate knowledge of or relevant experience with Workflows, SAS Programs, EDR, LAB Process, Loadsets, Snapshot handling. -Excellent knowledge of the business processes for Study Setup and Data entry required. Deep expertise in the Oracle*Clinical (and neighboring applications) are favorable, such as intimate knowledge of or relevant experience with Treatments, Lab, Reference Ranges, Lab Groups, Labcat derivations, Batch data load, EDR. Desired Skills: - Expert understanding of the global clinical applications used (Oracle Clinical, Oracle TMS, Oracle RDC, CARE/RAGe, SAS, CRF Track) by training in the use and support of these applications (where applicable). - Experience with regulatory requirements and GCP - Familiar with BI's Guideline for Clinical Development (GCD) Please email your resume to - dan.wienczkowski@rightthinginc.com"

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