Principal Clinical Data Engineer
- Bayer Zydus
- 5 - 8 Years
- Hyderabad
- 3 years ago
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Job Description
POSITION 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.
YOUR TASKS AND RESPONSIBILITIES:
- 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.
WHO YOU ARE:
- 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 7 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
- Knowledge of Oncology Clinical Data is required
- Knowledge of Pharmacokinetic experience in clinical trials
Employement Category:
Employement Type: Full timeIndustry: Chemicals
Functional Area: IT
Role Category: Software Engineer
Role/Responsibilies: Principal Clinical Data Engineer
Contact Details:
Company: Bayer ZydusLocation(s): Hyderabad
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Bayer Zydus
Bayer Zydus Pharma Private Limited Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time.
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