Centralized Monitoring Therapy Area Lead
About the role
The Therapy Area Lead (CMTAL) is responsible for providing studies within his/her TA with Centralized Monitoring service in order to enable Risk-Based Monitoring ensure data quality and protect patient’s rights.
The CMTAL will guide the project team, study team and SMM at the initial stages of the studies to define centralized monitoring needs. The CM service will be executed by a group of CM analysts guided by CMTAL. In order to effectively execute the tasks the CMTAL will have a very good understanding of internal and external challenges in data quality including results of regulatory submissions in the Therapy Area.
Importantly these accountabilities will be achieved by extensive collaboration and alignment with the Data Management, Biometrics and Information Sciences (B&I), Therapy Areas (TAs), Site Management and Monitoring (SM&M) and other internal and external stakeholders.
This role is located within Operational Enablement/Study Management and Operations/Clinical Operations in Global Medicines Development (GMD) and reports to Associate Director Centralized Monitoring.
Candidate Focus & Challenge
- Ensure studies are provided with centralized monitoring service in order to:
- enable risk-based monitoring
- secure data quality that will support regulatory submissions and robust investment decisions
- support protection of study participants rights
- Maintain high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
- Create and maintain TA-specific metrics and risk indicators (M&RI) in the CM M&RI library
- Contribute to the development of CM methodology
- Engage project teams, study steams and SMM in the initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates and risk management strategies
- Author Risk-based monitoring plans for studies soliciting and incorporating input from project teams, study teams, SMM, DM and B&I
- Lead the team of CM analysts in delivery of Centralized Monitoring services to studies including regular reviews of study data, provision of information to stakeholders, follow up of actions
- Ensure transfer of leanings between studies within the Therapeutic Area
- Ensure assessment of CM services effectiveness in completed or terminated studies
- Develop, coach, mentor, motivate and inspire individuals within the CM organization especially in the therapy area of interest
- MSc Degree or equivalent in the life sciences or related discipline
- Scientific background is beneficial
- Excellent knowledge of Risk-Based Monitoring (RBM) methodology and tools, industry trends, and role and place of CDM within RBM.
- Solid knowledge of basic statistical tools and methods used for centralized monitoring
- Previous experience from RBM and CDM is advantage
- Excellent knowledge of clinical trial monitoring and Study Team processes
- Comprehensive knowledge of clinical and pharmaceutical Drug Development Process.
- Comprehensive knowledge and understanding of Clinical Operations technology and standards, Clinical Data Management, Monitoring practices and regulations, GCP and quality requirements in clinical trials
- Clinical Operations experience within the therapy area of interest
- Ideally has experience in more than one company and/or geographical region
- Solid computer skills are necessary (e.g. advanced excel)
- Programming skills (SAS, R) are 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
- Good spoken and written English
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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.