This expert level Business Consultant position supports the business area utilizing clinical database and complementing applications. The supported systems include the clinical database management system (such as Oracle Clinical, RDC), in particular related to clinical trial data and trial management.
Participation in international software system implementation projects under general direction of CAS Line Manager and Business Project Responsible.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
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.
Participation in international software system implementation projects
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.
Assume ownership of problems. Ensure timely and competent support of user community with regard to 2
level problem. Decide on best problem solution in behalf of the global BDM user community and with minimum supervision.
Support user responses to regulatory inquiries. Increased attention and immediate support for distinguished “high priority” trials.
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 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.
Exploring new technology for use in BDM globally.
Relevant work experience typically 9 - 13 Years with BS, 7 - 11 Years, with MS, 4 - 8 Years with PhD.
4-7 years experience in the pharmaceutical industry to have a thorough understanding of the business function.
3-5 years experience with global clinical application principles in order to apply these principles to user requirements and support system development.
1-2 years experience with project management to manage the process implementation and enhancement tasks this position is responsible for.
In-depth knowledge and experience with Oracle LSH required.
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.
Must be legally authorized to work in the United States
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Clinical Research/Medical Affairs/Drug Regulatory Affairs
BI Pharma/BI USA
As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...