About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We 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.
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 Senior Trial Master File Compliance Manager, you will take a strategic view to ensure consistent, inspection-ready TMF compliance across clinical programs and portfolios. This role oversees TMF governance, quality oversight, and operational excellence, ensuring alignment with global regulatory requirements, the TMF Reference Model, and internal standards.
The Senior Manager partners with Clinical Operations, Quality Assurance, Records Management, and external partners (e.g., CROs, vendors) to drive TMF process improvements, lead audit and inspection readiness activities, and monitor performance metrics across studies.
The role includes mentoring TMF compliance staff, leading cross-functional working groups, and influencing enterprise-wide TMF initiatives such as technology enhancements, SOP development, and training frameworks.
You will act as a key escalation point for TMF-related compliance issues and plays a critical role in shaping and maintaining a high-quality TMF environment that supports the integrity of clinical trial documentation and regulatory submission readiness.
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.
- Develops standards and training materials related to TMF compliance.
- Oversees scheduling and management of compliance checks, while providing guidance to other TMF Compliance Managers.
- 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:
- Demonstrable experience of TMF related regulations and industry standards.
- Strong working knowledge of the TMF reference model.
- High level understanding of inspection/audit processes.
- Experience preparing TMFs for inspection.
- Proficient in electronic TMF systems e.g. Veeva Vault.
- Experienced developing or implementing TMF governance frameworks as well as tracking quality metrics, KPIs, dashboards.
Preferred Knowledge & Experience:
- Familiar with system configuration, role-based access and customization with platforms such as Veeva Vault.
- Experienced in leading or participating in eTMF system upgrades, migrations, validation testing.
- Ability to interpret complex reports and create actionable insights for study teams and leadership.
- Understanding of clinical project lifecycle management.
- Experienced working in a matrixed project team, managing competing timelines, priorities and change control processes.
Education:
- Bachelor’s Degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Poland.
- This position follows our hybrid working model.
- This role requires a blend of home and a minimum of 1-2 days per week in our Warsaw office. Flexibility may be required in line with business needs.
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.
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