Senior Data Management Systems Programmer, Rave
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 we gear up to expand our team in the UK, we are looking to recruit a Senior Data Management System Programmer for our Clinical Rave Programme.
You will evaluate, develop, maintain, and support clinical data systems which are used to collect, review, and analyze data in Astellas phase I-IV clinical trials. You will lead and manage clinical database programming activities on multiple studies according to agreed processes, standards and timelines.
This is a unique opportunity to be part of our global data management team that collaborates in managing best practices and standards to maintain, enhance, improve, and innovate on efficient processes for clinical data systems programming.
We are looking for an individual with excellent verbal and written communications skills, with the ability to work and influence various stakeholders across multiple discipline in an international environment.
Hybrid Working
At Astellas we recognize 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; optimizing the most productive work environment for you to succeed and deliver.
Key activities are noted below:
- Designing, developing and testing clinical study EDC databases (Medidata Rave) including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions.
- Maintaining all supporting documentation for studies/systems in accordance with processes to ensure quality, traceability, and compliance.
- Providing expertise in evaluating complex study requirements, determines feasibility of complex protocols, visit schedules/folders, and advises on best approaches and implementation.
- Tracking issues in Medidata applications, work with Medidata to resolve, and escalate issues appropriately to senior management.
- Assisting in management of user access to clinical databases using iMedidata & Cloud Administration.
- Assisting in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug.
- Overseeing any activities outsourced to CROs for database build or database edit check programming.
- Acting as subject matter expert (SME) in support for authoring or updating any departmental documentation (e.g., training documents, process guidance).
- Identifying and communicating lessons learned, best practices and frequently asked questions.
- Ensuring clinical database process efficiency, proactively identifies any gaps, and works with DM team to implement alternative processes as necessary.
- Monitoring Data Management key performance indicators for clinical database systems and develops action/escalation plans accordingly.
- Analyzing problems of high complexity; develops and implements alternative solutions both internally and with vendors.
- Participating in installation, validation, and implementation of new software or key system upgrades.
- Providing expert level technical direction to less experienced team members to ensure highest quality results.
Essential Knowledge & Experience:
- Educated to degree level or higher (equivalent) in Computer Science, Informatics, or life science discipline.
- Demonstrated previous experience in pharma or CRO industry in a senior informatics or programming role.
- Strong cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical operations, with high level of expertise expected in the DM systems discipline. Demonstrated experience in leading system selection and implementation projects.
- Experience in clinical trial database design and management with EDC and other data systems. Medidata Rave EDC, including Rave EDC Custom Function programming experience is preferred.
- Experience with pharmaceutical clinical research and clinical database development and Agile processes.
- Experience with database structures and programming languages.
- Strong working knowledge of Drug Development Process, Software Development Life Cycle, Computer Validation Process, and GCP regulations.
- Extensive experience with the development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
Additional information:
- This 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.