PAt Astellas we are a progressive health partner, delivering value and outcomes where needed. /ppWe 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. /ppWe 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. /ppOur 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. /ppWe 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. /ppBeyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. /ppbThe Opportunity : /b /ppAs a Clinical Site Manager (CSM), 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. /ppYou 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. /ppbHybrid Working : /b /ppAt 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. /ppbResponsibilities : /b /pulliActing as a primary local company contact for assigned sites for specific trials. Trials may include both early and late-phase clinical trials. /liliDriving 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. /liliBeing 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. /liliEnsuring 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. /liliTaking 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. /liliStrong working knowledge of GCP, local laws and regulations, assigned protocols, and associated protocol-specific procedures including monitoring guidelines. /liliSolid experience in Oncology, Ophthalmology, and / or Gene Therapy. /liliStrong IT skills in appropriate software and company systems. /liliExtensive site monitoring and / or site management experience. /liliProficient in English and the primary language of the country of employment. /li /ulpbPreferred Experience : /b /pulliWorked cross-functionally and within matrix teams. /liliMentored junior site monitors and site managers. /liliInvolved in early development studies. /li /ulpbEducation / Qualifications : /b /pulliBA / BS degree in life science or equivalent. /li /ulpbAdditional Information : /b /pulliThis is a permanent, full-time position. /liliThis position can be based in the UK, Poland, Italy, Germany, and Australia. /liliThis position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Milano office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. /li /ulpbWhat We Offer : /b /pulliA challenging and diversified job in an international setting. /liliOpportunity and support for continuous development. /li /ulpWe 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. /ppJ-18808-Ljbffr /ppJ-18808-Ljbffr /p #J-18808-Ljbffr