Trial Master File Compliance Manager
About 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 prvides 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:
- 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 in developing or implementing TMF governance frameworks as well as tracking quality metrics, KPIs, and 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/Qualifications:
- University degree or equivalent.
Additional Information:
- 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 needs. Candidates must be located within a commutable distance of the office
Astellas’ Global Capability Centres – Overview
Astellas’ 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.
#LI-Warsaw
#LI-Hybrid
#LI-CC1