paid / full-time / Warsaw Poland
R Programmer/Developer in Centralized Monitoring
Location Warsaw, Mazovia, Poland Job ID R-082968 Date posted 07/10/2020
The R Programmer/Developer in Centralized Monitoring provides studies with Centralized Monitoring service in order to enable Risk-Based Monitoring, ensure data quality and protect patient’s rights
The Analyst will execute the centralized monitoring service for assigned studies using his programming skills. The Analyst will work based on monitoring plan engaging Therapy Area Leads when needed.
The employee will ensure that risk indicators to be monitored by centralized monitoring according to monitoring plan are correctly set up in centralized monitoring systems. Additionally throughout the duration of a study the analyst will be assessing the logical correctness of the monitoring action requests delivered to study monitors, study level information delivered to the study team and other information recipients. Additionally, ad-hoc report creation and data analysis throughout the study
is expected.
Candidate Focus & Challenge
- Study-specific set-up of the centralized monitoring system based on monitoring plan in cooperation with the Therapyarea Lead including:
- Cross-study reporting to Clinical Operations Leadership
- Study level reporting to Project Teams and Study teams
- Country level reporting to Local study Teams
- Monitoring action requests and alerts to Monitors
- Maintenance of the study-specific centralized monitoring system including regular checks of logical correctness of reports and actions requests
- Change control of the centralized monitoring system
- Communication with monitors and report recipients including training sessions and troubleshooting, follow-up of execution of assigned actions
- Creation of ad-hoc reports including interpretation and translation of user requests into technical considerations
- Review of data to reveal potential problems and reporting of unusual data patterns to Therapy Area Lead
- Communication with the CM Technology Expert (CMTE) regarding system performance and improvement
Qualifications
- Knowledge and experience in R programming is essential
- Scientific background is advantage
- BSc Degree or equivalent in the life sciences , technology or related discipline
- Comprehensive knowledge and understanding of Clinical Operations technology and standards, Clinical Data Management, Monitoring practices and regulations
- Knowledge of Risk-Based Monitoring (RBM) methodology and tools, industry trends, and role and place of
- CM within RBM will be an advantage
- Solid computer skills are necessary (e.g. advanced excel)
- Previous experience from RBM and CM is an advantage
- Good knowledge of clinical trial monitoring and Study Team processes
- Good knowledge of clinical and pharmaceutical Drug Development Process
- Strong focus on delivery with high quality
- Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.
- Experience working internationally
- Good spoken and written English
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.