Clinical Database Programming Lead

At Astellas, we strive to become a cutting-edge, value-driven life science innovator.  This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us :

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Purpose and Scope :

The Clinical Data Enablement (CDE) Database Programming Technical Designer will perform the creation and maintenance of clinical databases for Phase I-IV clinical trials executed by Astellas.  An example of a clinical database would include an electronic data collection system (EDC) but could also include other data collection or review systems as appropriate.

The Technical Designer (TD) works as part of a project team to develop specification requirements, implement and maintain Medidata Rave clinical databases and system used to collect, review and clean data in Astellas’ phase 1-IV clinical trials.

To translate functional requirements into detailed technical specifications that database programmers can implement.

Ensure technical feasibility, scalability, and alignment with organization level standards.

Act as a liaison between Database Programmers, Data Managers and clinical teams ensuring clarity and consistency.

The Technical Designer (TD) will actively search for solutions which reduce set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.

Development and improvement of standards, templates, and process to improve efficiency and quality of databases / database set-up is expected along with a level of technical expertise that evokes innovation.

Responsibilities and Accountabilities :

Technical :

• Lead and manage study setup activities for multiple studies of varying complexity, adhering to established processes, standards, and timelines.
• Designs, develop specifications, and tests clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.
• Provides study-level support to teams and junior team members, assessing the protocol, evaluating alternatives, and facilitating resolution.
• Creates, reviews, and approves technical specifications for data management systems.
• Supports databases build specification development, including eCRFs, change requests, edit checks, custom functions, derivations, interface configuration, and migrations.
• Help resolve metadata anomalies and quality issues.
• Contributes to the creation of departmental documentation, such as training materials and process guides.
• Continuously seeks improvements in processes and templates to enhance operational efficiency.
• Oversee the activities of CRO vendors for outsourced data management systems, ensuring compliance with Astellas and industry best practices and timelines.
• Maintains regular communication with CRO staff, addressing questions, resolving issues, and mitigating risks.
• Provides expert-level technical guidance to junior team members, ensuring the delivery of high-quality results.
• Identifies and communicates lessons learned, best practices, and frequently asked questions.
• Maintains supporting documentation for studies and systems, ensuring quality, traceability, and compliance.
• Helps end users understand challenges and analyzes current processes to ensure context, implications, and expectations are clearly represented in the final solution.

Quantitative Dimensions : Oversees the development and maintenance of 18-20 studies per year.