Bayer jobs - Clinical Data Reviewer

POSITION PURPOSE:

Manage and conduct cross-functional Central Data Review in collaboration with study teams for early detection of issues and signals for assigned studies. Apply and contribute to design and development of data analytics methods and solutions for early issue detection, trend analysis and process performance analysis to enable oversight and to ensure high quality of data collected in ongoing clinical trials.

YOUR TASKS AND RESPONSIBILITIES:

• Collaborate globally with study teams and manage and conduct cross-functional Central Data Review for early detection of issues and signals for assigned studies, internally run as well as outsourced trials, across different therapeutic areas, interventional studies phase 1 to 4
• Perform holistic review of aggregated clinical, quality and performance data and pro-actively address quality or performance issues jointly with the study teams in line with issue management and risk-based quality management processes
• Apply and contribute to design and development of data analytics methods and solutions for early issue detection, trend analysis and process performance analysis to enable oversight and to ensure high quality of data collected in ongoing clinical trials
• Contribute to process improvements and development of efficient procedures for Central Data Review and other cross-functional data quality related initiatives
  
  

WHO YOU ARE:

• Bachelor in natural sciences, medical documentation, data science, statistics or related life science field
• At least 5 years of experience in the role of Clinical Data Manager, Central Data Reviewer, Study Lead Monitor, Data Scientist, Data Management Programmer or Statistical Analyst or in a similar function related to clinical development or data analysis, preferably with more than one role assumed
• Broad business understanding of clinical development processes, good understanding of regulations and guidelines like ICH, GCP and experienced in clinical data standards and terminology
• Excellent understanding of and experience in all aspects of data cleaning procedures
• Good understanding of and experienced in data analysis, data exploration, data visualization and KPI, KRI, KQI concept in context of clinical development and study conduct
• Experienced with respective tools like Medidata RAVE, Oracle LSH, MS Excel, JReview and Spotfire
• Strong interpersonal skills, excellent written and verbal communication
• Ability to work effectively both independently and in cross-functional teams
• Fluent in English, both written and spoken