Clinical Data Programmer, Repository Systems
About Astellas:
At Astellas we 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 Life Sciences 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 minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About this job:
As part of our global expansion, we are looking to recruit Clinical Data Repository Systems Programmers at various levels, to join our Data Management Systems Programming team.
In this role, you will take ownership of programming and configuring Astellas’ clinical data repository systems including system setup, data validation, reports and analytics programming.
This is a unique opportunity to join our global data management division in which you will be encouraged to not only maintain but enhance, improve and innovate processes for clinical data systems programming.
We are therefore looking for applicants with the able to work collaboratively with and influence individuals in cross-functional teams, across multiple disciplines and in an international environment.
Key activities are noted below:
- Managing (create, update, support) clinical data repository system setup (elluminate) of studies using system and study specific configurations, templates, and standards. This includes data mappings, reports programming, analytics programming, study setup, system configurations and applicable documentation (e.g., technical specifications, approval forms).
- Participating in Astellas end-to-end process to perform programming and setup activities such as data analysis, analysis, design, quality control, peer review, unit testing, user acceptance testing support, data setup, document authoring and reviews.
- Ensuring all related programming activities are complete per Astellas quality documents, standards, templates, and best practices.
- Improving technical processes to enhance efficiencies and leverage innovative solutions.
- Providing technical solutions to end users and stakeholders to support their challenges, understand the current state and requirements, and provides well-informed and innovative alternatives and solutions.
Essential Knowledge & Experience:
- Strong cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical operations, with a high level of expertise expected in the DM systems discipline. Demonstrated experience in leading system selection and implementation projects.
- Previous experience in pharma or CRO industry in an informatics or programming role.
- Strong computer skills, including database software management, reporting tools, medical coding tools or similar programmes.
- Solid knowledge of various programming methodologies and end to end system life cycle processes (e.g., Lean/Agile Methodology, Waterfall Methodology, SDLC).
- Strong understanding of different types of data sources and data integrity principles in clinical trials.
- Expert level understanding of data integrity principles and other associated industry, clinical and regulatory level best practices and requirements (e.g., GxP, GDPR).
- Advanced-level experience with T-SQL or PL-SQL programming.
Preferred Knowledge & Experience:
- Experience of working with eClinical Solutions ‘elluminate’ is preferred, or similar.
Educations/Qualifications:
- Educated to degree level or higher (equivalent) in Computer Science, Informatics, or a life science discipline
Additional information:
- The is a permanent full-time position based in the UK.
- We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.
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.