Central Monitoring Tools (CMT) Systems Programmer, CluePoints
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:
Would you like to join a team, that foster inquisitive and collaborative ways of working? We currently have multiple vacancies for a Central Monitoring Tools (CMT) Systems Programmer (CluePoints).
You will support the study level centralized monitoring (CM) tool development for Astellas drug development projects and will perform related programming activities. This may also include mentoring junior team members.
You will also support the data surveillance strategy development for centralized and statistical monitoring.
This is an excellent opportunity and be part of our global team with members in the US, UK, China, and Japan, that supports global studies and central monitoring processes.
We are looking for individuals with excellent interpersonal and communications skills, with ability to influence various stakeholders, providing innovative ideas and solutions.
Key activities are noted below:
- Reviewing and configuring the technical components of the CluePoints tools for studies.
- Supporting the data-driven components and system reporting needs for key CM activities (including Key Risk Indicators (KRI), statistical monitoring output, Quality Tolerance Limits (QTLs)and site risk review).
- Ensuring all related programming activities are complete per Astellas quality documents, standards, templates, and best practices.
- Supporting the centralized monitoring plan and collaborates with the study Central Monitor to make any systems/programming updates over the course of the clinical study.
- Reviewing and interpreting multiple data sources to identify potential issues with study sites or data quality with the study team.
- 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 provide well-informed and innovative alternatives and solutions.
Essential Knowledge & Experience:
- A degree or equivalent in Computer Science, Informatics, or life science discipline; demonstrated previous experience in pharma or CRO industry in an informatics or programming role.
- Demonstrated competence in DM systems, inclusive of all activities from study start-up to DB Lock.
- Solid understanding of relational database structure.
- Solid cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical operations, with previous expertise expected in the DM systems discipline.
- 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.
- Previous experience as clinical study manager, data manager or biostatistician, with progressive levels of responsibility.
- Experience with CluePoints (or other RBQM tools).
Preferred Knowledge & Experience:
- Experience in supporting multiple therapeutic areas or disease state/indications.
- Programming experience with SAS, Python, R is strongly desired.
- Prior technical report writing experience preferred.
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.