Principal Clinical Data Engineer

hace 4 semanas

Murcia, Murcia, España Bayer A tiempo completo

Becoming a Principal Clinical Data Engineer 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. Our team at Bayer is committed to making this vision a reality by working together with diverse minds to make a real difference.

Purpose: We are seeking a technical expert who will lead the implementation of the Medidata and Oracle product suite in clinical studies for data processing. This includes 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.

Key Tasks:

  • Develop and implement strategies: For software, integrations, and data review tools within existing business processes.
  • Lead 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 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.

Scope: Global

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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