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Job Location: Bengaluru
Job Detail:
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
POSITION 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 dataenvironments within a Therapeutic Area or Global Standards Implementation.
YOUR TASKS AND RESPONSIBILITES:
- 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 transferspecifications
- 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 tostudy related requests or issues
- Ensure adherence to program development, validation, and maintenance principals to produce high quality data in line with SOPs, OIs and BestPractice 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 andIOs
- Estimate the time and resources needed to complete assignments.
- Track work progress and provide status reports to line manager and study
- Team representatives
- Clinical trials data is a highly regulated and compliance driven environment. The timely setup/support of clinical data environments and therespective 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.
WHO YOU ARE:
- 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 #5+ 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.
- Knowledge of Pharmacokinetic experience in clinical trials.
- Excellent oral and written communication skills in a global environment
LIFE ATTRIBUTES:
- Be Accountable
- Collaborate and Connect
- Go Digital
- Play to Win
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
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