Senior Risk Based Quality Management Lead is responsible for providing assigned studies with Centralized Monitoring service to ensure compliance with ICH-GCP R2, Risk-Based Quality Management process and to safeguard clinical trial integrity and patient’s safety. 

Senior Risk Based Quality Management Lead will work closely with Global Study team, Local Study Team and CM Clinical Data Scientists at the initial stages of the studies to define centralized monitoring needs. Sr RbQM Lead will coordinate and oversee work of CM Clinical Data Scientists to define and execute centralized monitoring support in eligible studies/projects. In order to effectively execute the tasks, the SrRbQM Lead will have a very good understanding of internal and external challenges in data quality including results of regulatory submissions in the Therapy Area.

Typical Accountabilities

• Will work independently and take responsibility for specific Centralized Monitoring (CM) and Risk Based Quality Management (RbQM) deliveries within assigned studies
• Acts as a Subject Matter Expert and a trainer in CM functionalities/outputs for Global and Local study teams and other end users    
• Proposes and drives improvements to current CM/RbQM process to drive quality mindset and efficiencies
• Ensures that Critical to Quality factors (CtQ) are monitored by Centralized Monitoring according to IQRMP and monitoring plan
• Reviews data pertaining to specific CtQs on ongoing basis to reveal any outlying trends, risks of systemic errors etc.This will include facilitation of regular CtQ data review meeting with global study team, providing feedback to other stakeholders from local and global organizations
• Under supervision may lead some or all of the activities related to SQRMP
• Leads delivery of specific tasks in assigned study or CM initiative with other CM staff
• Acts as a champion, representing CM during cross-functional AZ activities

Education, Qualifications, Skills and Experience

Essential

• Education: Minimum of a BSc degree in Life Science
• Minimum 2 years of experience in the Biotech/Pharma/CRO industry
• Solid knowledge of Risk-Based Monitoring (RBM)/Risk based Quality Management (RbQM) and Centralized Monitoring methodology and tools
• Proven good analytical skills (experience with data trend analysis, graph and charts reading)
• Team organizer
• Demonstrated current understanding of GCP and regulatory requirements as they relate to RBM/RbQM
• Project Management and risk management skills
• Strong communication and interpersonal skills
• Very good communication skills in both written and spoken English                                                                                                        
• Ability to work in a global team environment

Desirable

• Good project management skills 
• Demonstrated knowledge of clinical and pharmaceutical drug development process
• Previous experience in working in RbM/CM related role
• Ability to interact effectively with senior management

Key stakeholders and relationships

Internal (to AZ or team)

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

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.