Specialist II/III, Clinical Applications Support-CDBR

Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager) Our CultureAt Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do. Specialist II/III, Clinical Applications Support-CDBR REQUIREMENTS:  Relevant work experience, typically 5 - 8 years with BS, 3 - 6 years with MS. 4-6 years experience in the pharmaceutical industry to have a thorough understanding of the business function. 2-3 years experience with global clinical application principles in order to apply these principles to user requirements and support system development. Experience with project management favorable in order to manage the process implementation and enhancement tasks this position is responsible for. Expert understanding of the global clinical applications used at BI (Oracle Clinical, Oracle TMS, Oracle RDC, CARE/RAGe, SAS, CRF Track, PPD Patient Profiles) by training in the use and support of these applications (where applicable). The training is documented via completed training certificates. Good verbal and written communication skills. Good negotiation and team-working skills. Experience with regulatory requirements and GCP. Familiar with BI's Guideline for Clinical Development (GCD). Successfully demonstrated time management, prioritization, and scheduling skills. Experience with Microsoft office suite of products, including MS PowerPoint..DUTIES & RESPONSIBILITIES:        Global Business Process Responsible (user support) 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. Contribute to identify the 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. Ensure information flow to user group. Develop training package/materials as directed and conduct training. 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 conduct 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, assist in determining user requirements together with a user group for a particular business process. Plan and conduct the CAS activities with regard to implementation of a particular process. Exploring new technology for use in BDM globally.  Corporate Site