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Principal Clinical Data Engineer Purpose: Technical expert will lead implementation of applicable Medidata and Oracle product suite in studies for data processing (Oracle database, LSH, DMW, RAVE, SG, iMedidata, Patient Cloud, etc.)
including other clinical trial applications.
He / She will be leading the setup of processes for technical tools to facilitate receipt and management of data from internal and external data providers using the available technology platforms (i.e., LSH).
He / She must define the setup and maintenance of integrations in studies for Import into and Export out of RAVE, LSH.
He / She leads the setup of technical utilities to facilitate receipt and management of data using the available technology platforms.
Design and execute tasks governed by technical standards and regulatory requirements with flexibility to enable collection and processing of new and unstructured sources of data (e.g., Digital / Device data directly from patients).
Scope (global, regional or local): Global Key Tasks: Establish implementation strategy for software, integrations and data review toolkits within existing end to end business processes.
Lead technical implementation for the software tools (Rave, LSH, MDR, DMW) and integrations to be used in data collection and processing.
Lead software evaluation activities with software vendors and IT partners (i.e., SIS, BBS) in context of operational usage with end to end interoperability.
Lead enablement of common technology platforms for data acquisition and processing, integrations, and utilities for internal and outsourced clinical trials.
Lead technical design, build, maintenance of software utilities for usage by study teams for data acquisition and data management in clinical trials.
Designs and documents operational processes for adoption of new and updated software utilities, integrations and toolkits aiming for process and toolkit connectivity across platforms such as Rave, LSH, MDR, DMW.
Lead implementation of quality and reconciliation activities for external data (i.e., Central Labs, ECG, adjudications) within studies.
Support implementation of data provisioning for usage in studies for clinical trial reporting with appropriate data models.
Participate in validation activities related to software utilities and integrations release.
Includes testing, writing test scripts, validation plans and associated reports.
Collaborate with functional representatives to provide software related technical and process training.
Key Working Relation: Internal: Interact within and outside of DS&A to ensure technical and data requirements are well understood and implemented consistently across studies and vendors.
Interact with internal IT partners to establish a strong knowledge base of the technology platforms.
Interact with functional teams to define and standardize requirements for implementation of integrations at study level.
External: Participate with Bayer teams in vendor relationship management to ensure successful study execution model.
Represent DTI with external IT providers to troubleshoot and support maintenance of systems including innovation and enhancements in the area of technology platforms.
Qualification & Competencies: Master's / Bachelor's degree.
10 years in-depth experience in design and developing tools and utilities on commonly used technology platforms (i.e., RAVE, LSH, DMW, Patient Cloud, Oracle Clinical) for data acquisition and associated review, and reporting (i.e., JReview, SpotFire) is required.
Knowledge and hands-on experience in programming languages such as C#, SQL, PL/SQL, JAVA, SAS is required.
Knowledge and experience in clinical trial start up, conduct and close out activities and associated technical best practices.
Hands-on experience with the tools and utilities for the management of pharmaceutical sponsor proprietary or industry clinical data standards (i.e., sponsor specific or CDISC) is required.
Understanding of industry standards on integration technology such as web services and odm.xml is also required.
Effective time management skills to ensure completion of assigned task within planned timelines is required.
Understanding of global regulatory requirements, rules and guidances associated with Source Data in Clinical Investigations including CFR part 11 is required.
Experience in project management tasks and managing multiple integrations and toolkits as assigned is desired.
Experience in comprehensive software validation activities using different methodologies (i.e., waterfall, agile etc), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle is required.
Effective interaction and training of teams in the understanding and usage of standards and technology is desired.
Effective written and verbal communication in English and usage of Microsoft Office is also necessary.
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