AstraZeneca Pharmaceuticals LP Centralized Monitoring Analytics Lead in Warsaw, Poland
The CM Analytics Lead (CMAL) will work with CM Analysts (CMAs) and CM Therapy Area Leads (CMTALs) to ensure implementation of CM functionalities in a way that meets business requirements emerging from CtQ-related standards. CMAL will also bring technology perspective into descriptions of CM functionalities in CtQ-related standards.
CMAL will contribute to identification and selection of areas to be addressed by new CM functionalities and support CMTALs and CMAs in gathering requirements and choosing proper approaches to new types of analyses.
CMAL will collaborate closely with CM System Owner (Enablement) in: development and maintenance of CM technology framework, representing CM Team to AZ stakeholders involved in transformation and constant improvements of technology framework in Clinical Operations, communicating business requirements and ensuring their proper realisation.
This role is located within Centralized Monitoring, Clinical Operations Therapeutic Areas, Clinical Operations and reports to Associate Director Centralized Monitoring.
CM Analytics Lead will:
oversee implementation of CM functionalities (CM dashboards, visualizations and monitoring action requests) to ensure they are built to meet business requirements that emerge from CtQ-related standards
provide input to descriptions of CM functionalities in CtQ-related standards to ensure their consistency and correctness from analytical and technical perspectives;
act as CM technology system expert providing guidelines and support to CM team members on the system functionality, defining best practices and collaborating with CM System Owner (Enablement) in an implementation of an agreed business process.
contribute to identification and selection of areas to be addressed by new CM functionalities and support CMTALs and CMAs in gathering requirements and choosing proper approaches to new types of analyses
collaborate with CM System Owner (Enablement) in:
development and maintenance of CM technology framework, including CM data model;
overseeing implementation of CM functionalities within CM technology framework to ensure they follow current good practice
representing CM Team to the external technology teams (e.g. Global IT Team) and working groups involved in transformation and constant improvements of technology framework in Clinical Operations, communicating business requirements and ensuring their proper realization;
MSc Degree or equivalent in the life sciences or in informatics / computer sciences
Excellent knowledge of Risk-Based Monitoring (RBM) methodology and tools, industry trends, and role and place of CM within RBM.
Understanding of clinical trial monitoring and Study Team processes, Clinical Operations technology and standards, Clinical Data Management, Monitoring practices and regulations, GCP and quality requirements in clinical trials
Programming skills (R, SAS or Python) are an advantage
Knowledge of statistical tools and methods used for centralized monitoring is an advantage
Previous work experience in RBM model and CM is an advantage
Excellent communication and influencing skills
Ability to interact with Senior Management.
Strong focus on delivery with high quality
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.
Experience working internationally: working with major markets/resolution of international issues
Teamwork and cross functional Collaboration: Is effective in leading and being a member of teams, both locally and internationally.
Business planning skills: has knowledge/experience of planning processes used in drug projects
Experience on effective Risk management
Very good spoken and written English
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.