Senior Manager, Study Management

DescriptionSenior Manager, Study ManagementLocation: Warsaw, Poland - hybridAbout AstellasAt Astellas we are a progressive health partner, delivering value and outcomes where needed.We pursue innovative science, focussing 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 OpportunityAre you ready to make an impact in global healthcare? We are looking for a Senior Manager, Study Management to join our Global Medical Affairs team. In this role, you will lead the operational planning and execution of post-approval research studies, including observational and non-interventional projects. Your work will help generate high-quality evidence that supports better patient outcomes and informs medical practice worldwide.This is a great opportunity for someone who enjoys working in a dynamic, international environment and wants to contribute to meaningful research that matters.Hybrid WorkingAt Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.Key Responsibilities Lead study operations: Plan, initiate, and manage assigned studies with operational excellence. Manage resources and timelines: Ensure effective budget control and timely delivery of study milestones. Collaborate globally: Work with cross-functional teams, vendors, and study sites across multiple countries. Ensure compliance: Maintain high standards aligned with GCP/ICH guidelines and internal processes. Drive improvements: Participate in initiatives to enhance study execution and quality. Oversee data quality: Support timely data cleaning, analysis, and reporting of study results. Essential Knowledge & Experience Solid experience in global clinical trial management within pharma, biotech, or CRO. Strong project and financial management abilities. Proven leadership and vendor oversight experience. Excellent communication in English and ability to work across cultures. Mindset: Organized, proactive, and comfortable working in a virtual environment when needed. Preferred Knowledge & Experience Experience with audits and regulatory inspections. Knowledge of late-phase clinical development in Medical Affairs. Familiarity with global drug development and lifecycle management. Education/Qualifications University degree in a scientific field. Additional Information This is a permanent role based in our Global Capability Centre in Warsaw, Poland or in the United Kingdom 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’ Global Capability Centres – OverviewAstellas’ Global Capability Centre’s (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 behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.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.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. 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