Trial Master File Compliance Manager

Description Trial Master File Compliance ManagerAbout Astellas : At 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 Opportunity : As a Trial Master File Compliance Manager, you will be tactically accountable for ensuring the quality, completeness, and inspection-readiness of clinical trial documentation across the study lifecycle., ensuring TMFs are maintained in accordance with regulatory requirements, company SOPs, and industry best practices. Acting as a key liaison between study teams, TMF governance, Quality Assurance, and external partners, the TMF Compliance Manager provides expert guidance on TMF processes, regulatory requirements, and system best practices. This role supports audit and inspection activities, proactively monitors TMF health through analytics, and drives resolution of compliance issues through collaboration, training, and continuous improvement initiatives. Hybrid Working : At 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 :

• Support and lead inspection readiness, audit support and other compliance related topics for Clinical Operations.
• Supports study teams in training / guidance on TMF requirements & processes. A “go to” resource for teams to solve study specific TMF questions and queries.
• Actively reviews TMF Health data analytics, identifying gaps / issues & developing solutions to resolve in a timely manner. Escalates issues to functional leadership, TMF governance, and QA as needed to ensure TMF quality and team performance.
• Works with TMF MO, TMF Governance, & TMF Champions to identify training and oversight needs. Supports inspection readiness and preparation activities.
• Maintain TMF processes in line with the TMF Reference Model, HA guidance and industry standards.

Essential Knowledge & Experience :

Preferred Experience :

Education :

Additional Information :

We are an equal opportunity employer, and all qualified applicants will receive consideration foremployment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Warsaw#LI-Hybrid#LI-MO1