The qualified candidatewill be hired at the appropriate level commensurate with education/experience.
This expert levelBusiness Support Specialist position ensures the availability of clinicaldatabase and complementing applications to the users, predominantly supportingthe BI region North and South America. The supported systems include theclinical database management system (Medidata RAVE), the Clinical DataRepository (such as Oracle Life-science Data Hub system, LSH), SAS-basedreporting tools (such as CARE/RAGe), and neighboring systems (IntegratedReview). User Support for globalapplications and the Clinical business process worldwide
Participation ininternational software system implementation projects under general directionof CAS Line Manager and Business Project Responsible.
As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers. Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies' success. We realize that our strength and competitive advantagelie with our people. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion,mobility, networking and work-life balance. Our competitive compensation andbenefit programs reflect Boehringer Ingelheim's high regard for our employees.
- 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 BDS 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. 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 BDS (Biostatistics & Data Sciences) globally.
CDSS Business AnalystRequirements:
- Bachelor degree preferred, but not mandatory, with 2-4 years’ of global clinical applications experience.
- In lieu of a Bachelor’s degree, the following years of experience is required.
- 4-7 years’ experience in the pharmaceutical industry to have a thorough understanding of the business function, with 3-5 of those years related to global clinical application principles.
- Additionally, 1-2 years project management experience to manage the process implementation and enhancement tasks this position is responsible for.
- Knowledge and experience with clinical management, data or reporting applications required In-depth knowledge and experience with Oracle LSH required.
- Expert understanding of the global clinical applications used at BI (Medidata Architect, Medidata RAVE, Medidata Coder, BOXI/Crystal Reports) Experience supporting users through trial build, conduct and reporting is preferred. Also competent in training 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 locally and in a global context.
- 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.
CDSS Principal BusinessAnalyst requirements:
· Bachelor’s degree required. Master’s degree preferred with 5-7years of global clinical application experience. In lieu of a Master’s degree,the following years of experience are required.
o 9-11 years’ experience in the pharmaceutical industry to have athorough understanding of the business function.
- 9-11 years project management experience, to complete required tasks.
- 7-9 years’ experience with global Clinical Research application principles in order to apply them to user requirements and support system development.
- 5-7 years involvement with international teams.
- 5-7 years business process development to understand user and process requirements.
- 3-5 years regulatory requirements and ICH/GCP.
- Successfully demonstrated time management, prioritization and scheduling skills.
- Teamwork and strong customer focus.
- Experience in international work environment.
- Experience with Microsoft suite of office products.
- Strong presentation skills – development & implementation.
- Excellent verbal and written communication skills.
- Respected expert of Clinical Research applications by documented training, use, and support of these applications (where applicable).
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Who We Are:
At Boehringer Ingelheimwe create value through innovation with one clear goal: to improve the lives ofpatients. We develop breakthrough therapies and innovative healthcare solutionsin areas of unmet medical need for both humans and animals. As a family ownedcompany we focus on long term performance. We are powered by 50.000employees globally who nurture a diverse, collaborative and inclusiveculture. Learning and development for all employees is key because yourgrowth is our growth.
Want to learn more? Visit boehringer-ingelheim.com andjoin us in our effort to make more health.
Boehringer Ingelheim,including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC andBoehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmativeaction employer committed to a culturally diverse workforce. Allqualified applicants will receive consideration for employment without regardto race; color; creed; religion; national origin; age; ancestry; nationality;marital, domestic partnership or civil union status; sex, gender identity orexpression; affectional or sexual orientation; disability; veteran or militarystatus, including protected veteran status; domestic violence victim status;atypical cellular or blood trait; genetic information (including the refusal tosubmit to genetic testing) or any other characteristic protected by law.