Principal Clinical Data Engineer

hace 1 semana

Barcelona, Barcelona, España Bayer A tiempo completo

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Principal Clinical Data Engineer

Purpose:

"Provide and coordinate study/standard level technical programming support in collaboration with key stakeholders during setup, conduct and closeout activities ensuring a high level of consistency and quality within and across studies.

Provide and coordinate support for data structures definitions, monitor quality and standards adherence across studies.

Provide and coordinate study data transformation programming, data loading, data quality checks, data provisioning, and data information flow within and across studies in the clinical data environments within a Therapeutic Area or Global Standards Implementation.

Key Tasks:

Interpret protocol requirements to translate and document them into study level technical specifications.

Develop study level and study agnostic programs for setup, conduct and closeout activities in the clinical data environments.

Provision clinical study data to business consumers.

Perform and coordinate data loading / exchange activities (including data exchange with CROs and vendors) and ensure compliance against agreed data transfer specifications.

Facilitate requirements gathering from consumers and develop solutions to meet immediate and long-term needs of business customers.

Monitor and maintain ongoing study level operations of clinical data environments, respond to study issues.

Document agreed programming conventions within a Clinical Project, Therapeutic Area or Global Standards Implementation.

Collaborate with study team functional representatives to ensure a sound understanding of the technical platforms for standardized solutions to study related requests or issues.

Ensure adherence to program development, validation and maintenance principals to produce high quality data in line with SOPs, OIs and Best Practice Documents for all data models/environments inclusive of supporting ways to define/enable automation and efficient re-usability.

Serve as validation lead in compliance with respective SOPs, OIs and Best Practice Documents. Complete all documentation associated with programming tasks (e.g. validation, report specifications etc.) in compliance with applicable SOPs and IOs.

Ensure end-to-end data flow process where traceability requirements are met following Bayer Standards.

Estimate the time and resources needed to complete assignments.

Track work progress and provide status reports to line manager and study team representatives.

Participate and actively contribute to process optimization initiatives, including definition and documentation.

Closely collaborate and communicate within the group and across the organization. Participate in Knowledge Sharing forums within the group and across the organization.

Assist with the training of new hires and oversight of external resources.

Clinical trials data is a highly regulated and compliance driven environment. The timely setup/support of clinical data environments and the respective integrations is key to the provision of / access to that information and it is directly linked to the extent that the company can claim; prove its portfolio assets are safe, effective and marketable.

The Principal Clinical Data Engineer is responsible for providing and coordinating deliverables within and across studies managed within the clinical data environment

Key Working Relation:

Standards Management & Quality Assurance

Data/Medical Review Specialists Data Managers

Medical Coding Data Acquisition Specialists and Programmers

Technology and Application Management

Statistical Analysts

Statisticians

Learning & Communication

Qualification & Competencies:

Masters in a natural science, Statistics, Computer Science or a related field with 5+ years of experience in a technical environment or equivalent, focusing on data warehousing and/or extract, transform, load (ETL) activities.

Bachelors in a natural science, Statistics, Computer Science or a related field with 8+ years of experience in a technical environment or equivalent, focusing on data warehousing and/or ETL activities.

Experience in the pharmaceutical or biotechnology industry preferred.

Advanced knowledge of data warehousing principles, technologies and related ETL processes.

Previous experience in Oracle Life Sciences Data Hub (LSH) preferred, including advanced knowledge of core functionality of LSH, and familiarity with LSH best practices. Experience with metadata repositories, preferred.

Experience in performing ETL tasks and validating results. 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.

Experience with a variety of programming languages including but not limited to PL/SQL, JAVA, SAS, C #. 5+ years hands on experience in programming in SQL and Oracle PL/SQL, using SQL developer, TOAD or similar program development applications for realization of automations and programming activities in a regulated environment. Knowledge of clinical data mapping, transformation and end to end processes.

Ability to work in cross functional teams

Experience with 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

Knowledge of clinical data structures (i.e. CDISC standards for CDASH, SDTM and ADaM), preferred.

Excellent oral and written communication skills in a global environment

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