16 July, 2022
AstraZeneca Hiring Director, Centralised Monitoring
JOB TITLE : Director, Centralised Monitoring
CAREER LEVEL: F
Leverage technology to impact patients and ultimately save lives
Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!
About Our It Team
It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.
About The Role
The Director of Centralised Monitoring (DCM) is a member of the core Centralised Monitoring Leadership Team who contributes to the strategy for development, implementation and adoption of the Centralised Monitoring (CM) capabilities. CM is the centralized coordinated review of data and is one of the key components of Risk based Quality Management (RbQM), built on the structured process to identify risk and critical to quality factors for all studies from design through execution and reporting of the trial. This role will significantly contribute to broader adoption of RbQM in AstraZeneca. The DCM is accountable for line management of various roles in CM team (e.g. ADs RbQM, ADs Clinical Data Science). The DCM serves as a subject matter expert for assigned functional area to the peers within the CM Team and other partners as necessary and provides oversight of and ensures delivery of qualified support to Clinical Project Teams and Global Study Teams within oncology. The DCM supports the CM Head in the governance and broad implementation of CM including department performance and quality metrics. Implementation, improvement and maintenance of CM in RbQM is a part of A
Member of the core Centralised Monitoring Leadership Team (CMLT) expected to contribute to, and influence the future direction of the CM development
- Line management of direct reporting Senior Specialist RbQM, ADs RbQM, ADs Clinical Data Science, ADs Centralized Monitoring and other CM Team members, as appropriate, to support development of current and/or new capabilities within the team
- Works according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements.
- Serves as a subject matter expert for the assigned functional area to the peers within the CM Team and other partners as necessary
- Provides oversight of, and ensures delivery of qualified CM support to Clinical Project Teams and Global Study Teams within functional area
- Drives consistency of CM related documents and CM functionalities including oversight of performance and quality measures of these processes within functional area.
- Ensures delivery of CM and SET-area goals in the assigned functional area.
- Contributes to, and helps to drive development and execution of CM and RbQM strategy e.g., cooperates with the CM Head in development of implementation plans for new capacity and capabilities in the CM team
- Is responsible for development, build and maintenance of a long-term sustainable capacity, capabilities and onboarding training for all CM skills within the functional area
- Supports and acts as a back up of the CM Head in leading the governance, and implementation of CM as well as in development of, measurement and reporting of RbQM and CM department metrics
- Supports and deputises for the Head of CM in leading collaboration and communications across units so that RbQM and CM principles and methodologies and functionalities are developed, established, improved, and well understood to ensure delivery of the portfolio.
- Acts as a Subject Matter Expert in the field of Centralised Monitoring/RbQM or CM Analytics and works closely with Head of CM and the Global Head Clinical Data and Insights in driving mind shift required for successful RbQM adoption across R&D units.
- Supports the CM Head in collaboration with internal and external stakeholders to drive development of processes and technologies so that they are available, implemented, updated and documented to sufficient quality standard
Supports the Head of CM and the Global Head Clinical Data and Insights in implementation of quality control measurement and methods for review of RbQM and CM processes and deliverables. Works with the CM Head and internal and external technical experts to prepare CM for clinical development technology shifts like Electronic Health Record (EHR), wearables and sensors so these are fully leveraged for risk mitigation and quality management by inclusion of these data sources
- Proactively maintains inspection readiness from a CM perspective
- Ensures and documents that CM staff in the subordinate organization are adequately trained in process, tools and documentation
- Supports the CM Head in driving and maintaining budget targets including LRP forecasting.
- Maintains a positive, result oriented work environment, building partnerships and modelling team work, communicating to the CMLT and teams in an open, balanced, and objective manner
Education, Qualifications, Skills and Experience
Dependent on the overseen functional area:
- University degree (or equivalent) in Life Science, Computer Science OR Information Science
- Proven broad Clinical Development experience within the pharmaceutical industry or clinical research organization OR data science (minimum of 6 yrs)
- Excellent knowledge of Risk-Based Monitoring (RBM) / RbQM methodology and tools, industry trends, and role and place of CM within RBM
- Excellent knowledge of clinical trial monitoring and study processes
- Good understanding of clinical study statistical and data management processes.
- Proven track record of organizational change management
- Strong focus on delivery
- Excellent communication skills in written and spoken English
- Comprehensive knowledge and understanding of Development Operations technology and standards
- Ability to interact with senior management
- Experience in risk management Excellent collaborative capabilities with the ability to taking into consideration complex cross functional organizational needs
- International working experience
- Strong stakeholder management capabilities
- Travels domestically and internationally.
- Proven line management of experts (+10 individuals) with the ability to drive performance and growth
- Advanced degree is preferred
- Proven ability to develop collaborations with external partners
- Experience of working in complex global multi-national organizations would be a plus