We are now looking for (4) four professionals with experience with a variety of programming languages and knowledge of clinical data structures to work in a challenging global role based in our Data Science & Analytics (DS&A) group in Clinical Data Environment Management - Research and Early Development / Development & Medical Affairs department in Finland in Espoo as
CLINICAL DATA ENGINEER
Your tasks and responsibilities
- Interpret clinical protocol requirements to translate and document them into study level technical specifications.
- Develop study level programs for setup, conduct and close out 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. Track work progress and provide status reports to line manager and study.
Who you are
- Bachelor/Masters with proven experience in a natural science, Statistics, Computer Science or a related field with 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, Python, SAS, C #.
- Proven 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 English in a global environment.
We offer an interesting role in a global life science company with a chance to develop your skills further. To be considered for this exciting opportunity, please submit your application at your earliest convenience and no later than Monday August 30, 2021. Candidates will be reviewed on a continuous basis.
If you have questions about the position, you are welcome to contact Luiz Giorgiani, Head of Clinical Data Management RED II, Data Sciences & Analytics, by phone +358 400 807 868 on July 26, between 13.00-14.00 pm (EET) or on August 4, between 14.00-15.00 pm.
Functional area: Clinical Development & Operations
Seniority level: Professional
Location: Espoo, Finland