Clinical Data Engineer
hace 2 semanas
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.
Clinical Data Engineer Purpose:
Provide study/standard level technical programming support in collaboration with key stakeholders during setup, conduct and closeout activities. Provide study level support for data structures definitions, monitor quality and standards adherence.
Provide study data transformation programming, data loading, data quality checks, data provisioning, and data information flow in the Clinical data environments within a Therapeutic Area or Global Standards Implementation.
Scope (global, regional or local): global Key Tasks:
- Interpret protocol requirements to translate and document them into study level technical specifications
- Develop study level programs for setup, conduct and closeout activities in the clinical data environments
- Provision clinical study data to business consumers
- Perform data loading / exchange activities (including data exchange with CROs and vendors) and ensure compliance against agreed data transfer specifications
- Develop solutions based on gathered requirements from consumers 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
- 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
- Ensure end-to-end data flow process where traceability requirements are met following Bayer Standards
- Complete all documentation associated with programming tasks (e.g. validation, report specifications etc.) in compliance with applicable SOPs and IOs
- Estimate the time and resources needed to complete assignments.
team representatives 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 is directly linked to the extent that the company can claim; prove its portfolio assets are safe, effective and marketable.
The Clinical Data Engineer is responsible for supporting study level deliverables 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 Qualification & Competencies:
- Masters in a natural science, Statistics, Computer Science or a related field with 3 years of experience in a technical environment or equivalent, focusing on data warehousing and/or ETL activities
- Bachelors 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 ETL activities
- Knowledge of data warehousing principles, technologies and related ETL processes.
- Experience with metadata repositories, preferred
- Experience with a variety of programming languages including but not limited to PL/SQL, JAVA, SAS, C #
- 2+ years hands on experience programming in relational databases: 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 structures (i.e. CDISC standards for CDASH, SDTM and ADaM), preferred
- Knowledge of 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
- Excellent oral and written communication skills in a global environment YOUR APPLICATION This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer. Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Location:
Spain :
Cataluña :
Barcelona Division:
Enabling Functions Reference Code:
#J-18808-Ljbffr
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