At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
Your primary role in this position is to act as a study-level centralized monitoring contributor, supporting Astellas drug development projects of moderate to high complexity. You will require limited supervision and minimal day-to-day support from line management. In this role, you will represent Quantitative Sciences and Evidence Generation (QSEG) as a central monitoring subject matter expert and advocate for CM processes. As a Central Monitor, you will help implement and continuously improve procedures to ensure Astellas maintains a robust, comprehensive central monitoring program. This includes leveraging your expertise to develop processes and tools, as well as overseeing external partnerships with vendors performing study-level work.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.
Key Responsibilities:
• Lead Risk Assessment and central monitoring observation review discussions with the clinical study team. Supports the team in assessment and mitigation of centralized monitoring observations to identify potential issues and risks occurring during study conduct.
• Review study-level KRIs, QTLs, statistical monitoring data outputs in aggregate across sites, regions, and countries.
• Contribute to activities that define, deliver, and optimize the centralized monitoring capabilities and processes.
• Develop the central monitoring and data surveillance plan, incorporating feedback and discussion with the study team to capture the study requirements for the study-specific central monitoring and data surveillance strategies.
• Facilitate and contributes to key activities of study start up, conduct, and close-out, including risk assessment, identification of critical data and critical processes, Key Risk Indicator (KRI) identification for study level centralized monitoring, and definition of appropriate thresholds to effectively monitor study progress around the associated KRIs and QTLs.
• Act as the study-level primary contact, and subject matter expert for the centralized statistical monitoring tool.
Essential Knowledge & Experience:
• Expertise in Risk-Based Quality Management (RBQM) methodologies.
• Demonstrated central monitoring analytical skills in multiple development programs, inclusive of all activities from program inception to regulatory submission.
• Experience in CluePoints is a bonus.
• Strong computer skills, including database management software, data analysis &reporting tools, project management tools, etc.
Preferred Knowledge & Experience:
• Professional Certification in a clinical development discipline.
• Advanced degree preferred.
Education:
• BS/BA degree in biological science, statistics, health-related or computer science field or equivalent.
Additional Information:
• This is a permanent, full-time position.
• This position is based in the United Kingdom and Poland.
• Some limited, occasional travel maybe required.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone/Warsaw office. Flexibility may be required in line with business needs.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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