Clinical Data Engineer Lead

hace 2 días

Barcelona, Barcelona, España Bayer A tiempo completo
Principal Clinical Data Engineer

Bayer is a global leader in the life sciences industry, driven by a vision to make a meaningful difference in people's lives. We're seeking a highly skilled Principal Clinical Data Engineer to join our team and contribute to the development of innovative solutions for clinical trials.

Key Responsibilities:

  • Lead the implementation of Medidata and Oracle product suites in studies for data processing, including Oracle database, LSH, DMW, RAVE, SG, iMedidata, Patient Cloud, and other clinical trial applications.
  • 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, such as digital/device data directly from patients.
  • Establish implementation strategies for software, integrations, and data review toolkits within existing end-to-end business processes.
  • Lead technical implementation for software tools (Rave, LSH, MDR, DMW) and integrations to be used in data collection and processing.
  • Lead enablement of common technology platforms for data acquisition and processing, integrations, and utilities for internal and outsourced clinical trials.
  • Design and document 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 (e.g., 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, including testing, writing test scripts, validation plans, and associated reports.

Requirements:

  • Technical expertise in Medidata and Oracle product suites, as well as experience with clinical trial applications.
  • Strong understanding of technical standards and regulatory requirements in the life sciences industry.
  • Ability to design and execute tasks with flexibility to enable collection and processing of new and unstructured sources of data.
  • Excellent leadership and communication skills, with experience in leading technical implementation and enablement of common technology platforms.
  • Strong analytical and problem-solving skills, with ability to design and document operational processes.
  • Experience with quality and reconciliation activities for external data, as well as data provisioning for clinical trial reporting.
  • Ability to participate in validation activities, including testing, writing test scripts, validation plans, and associated reports.

What We Offer:

  • A dynamic and collaborative work environment with a team of experienced professionals.
  • Opportunities for professional growth and development, with access to training and development programs.
  • A competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
  • The chance to work on cutting-edge projects and contribute to the development of innovative solutions for clinical trials.

How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information]. We look forward to hearing from you

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