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Principal Clinical Data Engineer
hace 2 semanas
At Bayer, we're visionaries driven to solve the world's toughest challenges, striving for a world where 'Health for all, Hunger for none' is no longer just a dream but a reality. We do this with energy, curiosity, and dedication, learning from diverse perspectives, expanding our thinking, growing our capabilities, and redefining the impossible. If you're eager to build a meaningful career in a community of talented and diverse minds to make a real difference, Bayer is the place for you.
Principal Clinical Data Engineer
Purpose :
The technical expert will lead the implementation of the Medidata and Oracle product suite in clinical studies for data processing, including tools like Oracle database, LSH, DMW, RAVE, SG, iMedidata, and Patient Cloud. The role involves setting up processes for managing data from internal and external providers using platforms like LSH, and defining the setup and maintenance of integrations for data import / export in studies. The engineer will design and execute tasks according to technical standards and regulatory requirements, with flexibility to incorporate new and unstructured data sources such as digital and device data directly from patients.
Scope : Global
Key Tasks :
- Develop and implement strategies for software, integrations, and data review tools within existing business processes.
- Lead the technical implementation of software tools (Rave, LSH, MDR, DMW) and their integrations for data collection and processing.
- Evaluate software solutions with vendors and IT partners to ensure operational interoperability.
- Enable and support common technology platforms for data acquisition, processing, and utilities in clinical trials.
- Design, build, and maintain software utilities for study teams to facilitate data management.
- Document operational processes for adopting new or updated software utilities and integrations, ensuring connectivity across platforms.
- Implement quality control and reconciliation activities for external data sources like labs and ECGs.
- Support data provisioning for clinical trial reporting, ensuring proper data models are used.
- Participate in validation activities for software releases, including testing and documentation.
- Provide training and support to teams on software tools and processes.
Key Working Relations :
Internal : Collaborate within and outside Data Science & Analytics to ensure understanding and implementation of technical and data requirements. Work with IT to build knowledge of technology platforms and with functional teams to standardize requirements.
External : Engage with vendors and external IT providers to manage relationships, troubleshoot, and support system maintenance and enhancements.
Qualifications :
- At least 10 years of experience in designing and developing tools / utilities on platforms like RAVE, LSH, DMW, Patient Cloud, Oracle Clinical, including data review and reporting tools like JReview and SpotFire.
- Proficiency in programming languages such as C#, SQL, PL / SQL, JAVA, SAS.
- Experience in clinical trial start-up, conduct, and close-out activities, with best practices knowledge.
- Hands-on experience with data standards (sponsor-specific or CDISC) and industry standards for integration (web services, odm.xml).
- Strong time management skills to meet deadlines.
- Knowledge of global regulatory requirements, including CFR part 11.
- Project management experience managing multiple integrations and tools.
- Experience with software validation using methodologies like waterfall or agile.
- Ability to train teams on standards and technology effectively.
- Excellent written and verbal communication skills in English and proficiency in Microsoft Office.
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