Data Management Lead

As a Data Management Lead, you will be responsible for study-level data management activities of moderate to high complexity within a drug development program for Data Science (DS). This includes all aspects of DM deliverables (data standards, eSource, Medical Coding, database build, external data, central monitoring, etc.), and overall management/oversight of all data management. You will be also responsible for applying your external data expertise to standardize and streamline review and cleaning of data received through routes other than the EDC system. This role also works with external providers and other stakeholders to resolve data discrepancies throughout the course of clinical study conduct. 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 Activities for this role:

• Lead the data review meetings with Medical, Clinical Operations, Statistics, and Stats Programming in support of key reporting events or database lock plans.
• Create and maintains study level data transfer specifications (i.e., external data specifications).
• Process test transfers and liaises with the external data provider to verify the data structure and format.
• Define the study level specifications for reconciliation checks and exception listings to perform the reconciliation between EDC data and external data.
• Manage external data transfers, reviews the discrepancy output of reconciliation checks and exception listings, and works with Data Management, Study Management, Bioanalysis and/or Stats/Stats Programming and/or the external data providers to resolve discrepancies.
  
  Experience in pharmaceutical, clinical research or health services industry as Data Manager, with progressive levels of experience with varying study types and phases.
• Demonstrated experience in managing external data processes for data management. This includes creation of external data transfer specifications; leading study level UAT and QC of external data transfers; performing reconciliation data checks on external data.
• Experience with eSource systems/devices. And strong knowledge of the different data sources in a clinical trial setting.
• Solid understanding of international regulations for clinical trials (e.g. GCP) and familiar with CDASH/CDISC standards.
• Ability to communicate effectively and maintain effective relationships.
• Demonstrated learning agility, ability to adopt new data management technologies and capabilities.
Education/Qualifications:
• BS/BA degree in a biological science, health-related or computer science field or equivalent.
  
  Data Management Lead
About Astellas: At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The Opportunity


• This is a permanent, full-time position based in the UK.
• This position follows our hybrid working model. Role requires a blend of home and once per quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.