Clinical Site Manager

DescriptionClinical Site ManagerAbout 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 OpportunityAs a Clinical Site Manager (CSM II), you will serve as the primary contact point between the Sponsor and the Investigational Site. You will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up to site closure. You will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support.You will partner with the Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial-related activities for assigned protocols.This position reports to the Head, Late-Stage Site Monitoring. This role forms a part of the Clinical Operations, Development team. This position is based in Warsaw, Poland.Hybrid WorkingAt Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.Key Activities For This RoleActing as a primary local company contact for assigned sites for specific trials. Trials may include both early and late-phase clinical trials. Driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study-specific systems and other reports/dashboards), and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Being responsible for implementing risk-based monitoring approaches at the site level and working with the site to ensure timely resolution of issues found during monitoring visits. Ensuring source and other site documentation is adequate and in compliance with ALCOA-CCEA. Ensuring site compliance with the study protocol, ICH-GCP, and local/country regulations. Taking accountability for up to 10 sites across 2-4 protocols, dependent on the complexity of protocols and site activity. Being responsible for managing own travel budget within Astellas T & E guidelines. Essential Knowledge & ExperienceExtensive site monitoring and/or site management experience. Experienced working in early development studies within Oncology. Strong working knowledge of GCP, local laws and regulations, assigned protocols, and associated protocol-specific procedures including monitoring guidelines. Strong IT skills in appropriate software and company systems. Proficient in speaking and writing English and to be fluent in local language. Preferred QualificationsExperienced in executing Lead CSM role Worked cross-functionally and within matrix teams. Mentored junior site monitors and site managers. Education/QualificationsBA/BS degree life science or equivalent. Additional InformationThis is a permanent, full-time position. This position is based in Warsaw (Poland) 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’ 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.