Central Monitoring Lead
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
The primary purpose of the position is to act as a study level centralized monitoring contributor, supporting Astellas drug development projects of moderate to high complexity.
The individual represents Quantitative Sciences and Evidence Generation (QSEG) as an Risk Based Quality Management (RBQM) and central monitoring subject matter expert and advocate for CM processes. The Central Monitor will support the implementation and ongoing evolution of procedures to ensure Astellas maintains a robust, comprehensive RBQM (RBQM) central monitoring program. This includes providing subject matter expertise to the development of processes and tools, and to oversee our external partnerships with vendors performing study level work.
Role and Responsibilities
· Contributes to or facilitates the risk assessment for study teams
· Contributes to or develops the central monitoring plan, incorporating feedback and discussion with the study team to capture the study requirements for the study-specific central monitoring strategy.
· Contributes to key activities of study start up, conduct, and close-out, including: identification of critical data, 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.
· Acts as the study-level primary contact, and subject matter expert for the centralized statistical monitoring tool.
· Reviews study-level KRIs, QTLs, statistical monitoring data outputs in aggregate across sites, regions, and countries.
· Supports the team in assessment and mitigation of centralized monitoring observations to identify potential issues and risks occurring during study conduct. Leads central monitoring observations review discussions with the clinical study team.
· Ensures/oversees the execution of central monitoring deliverables for any outsourced components.
· Collaborate with study manager to investigate any identified issues with CRO monitoring partners, based on centralized monitoring findings.
· Throughout the study, and at study close, ensure all observations, investigations, and actions are documented and adequately stored in Trial Master File.
· Contributes to activities that define, deliver, and optimize the centralized monitoring capabilities and processes.
· May participate in vendor (CROs or technology providers) evaluation and provide feedback on performance as required.
Required Qualifications
· BS/BA degree in a biological science, statistics, health-related or computer science field. Advanced degree preferred.
· Experience in pharmaceutical, clinical research or health services industry.
· With demonstratable experience as central monitor, clinical study manager, data manager, or biostatistician, with progressive levels of responsibility
· Experience in Risk Assessments.
· Strong computer skills, including database management software, data analysis &reporting tools, project management tools, etc
· Fluency in written and spoken English
Preferred Qualifications
What awaits you at Astellas?
· Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
· Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
· Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
· A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
· Impact
· Innovation
· Integrity
· One Astellas
· Accountability
· Courage
· Sense of Urgency
· Outcome Focus
Benefits
Careers | Astellas
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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