Principal Risk Based Quality Management Lead drives RbQM process in assigned studies or projects to ensure compliance with ICH-GCP R2, AZ SOPs and to safeguard clinical trial integrity and patient’s safety. 

PRbQM Lead works closely with Global Project and Study teams, SrRbQM Leads and CM Clinical Data Scientists at the initial stages of the studies to define critical to quality factors, quality tolerance limits and risk management strategies as well as coordinates and oversees work of SrRbQM Leads and CM Data Scientists to define and execute centralized monitoring support in eligible studies/projects

PRbQM Lead contributes to RbQM process and CM strategy by driving standardization and defining best practices

Typical Accountabilities

• Leads RbQM process in eligible studies
• Acts as subject matter expert (SME) in area of RbQM and risk management both internally and externally
• Demonstrates good understanding of a broader CM strategy and contributes to it by driving cross functional innovation/optimization projects
• Maintains a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
• Engages project teams, global and local study steams during initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates, quality tolerance limits and risk management strategies
• Develops, coaches, mentors, motivates and inspires individuals within the CM organization especially in the therapy area of interest
• May oversee activities performed by Senior RBQM Lead
• Contributes to the development of CM methodology and CM best practices
• Expected to coach more junior staff and support functional development through e.g. recruitment, training and mentoring
• Acts as SME on RbQM/CM in AZ optimization/best practices initiatives

Education, Qualifications, Skills and Experience

Essential

• Education: Minimum of a BSc degree in Life Science
• Minimum of 4 years of experience in the Biotech/Pharma/CRO industry
• Has a deep understanding of the clinical development and risk based monitoring and centralized monitoring methodologies                                                                 
• Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management
• Excellent communication skills in both written and spoken English          
• Strong Project Management and Risk Management skills    
• Ability to mentor, train and lead teams in projects  
• Agile responsiveness to industry and business needs and embracing peers’ review
• Demonstrates strong cross-functional leadership skills

Desirable

• Experience in Risk Based Monitoring/Centralized Monitoring is highly desired
• Working in roles with global remit
• Excellent understanding and demonstration of the AZ values and behaviours

Key stakeholders and relationships

Internal (to AZ or team)

• Centralized Monitoring 
• Clinical Development and Insights   
• Study Management - Core Team/Extended Study Team Members
• Site Management & Monitoring – Local study teams
• Other Development Operations functions; among others: Clinical Project Team (CPT); senior management 

External (to AZ)

• Third party representatives of vendors/partners contracted to AZ 

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.