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.

Required Qualifications:

• Bachelor's degree in computer science or a related field, with at least 8 years of experience in the pharmaceutical industry.
• A minimum of 6 years of experience in clinical trial database design and management, specifically with EDC systems such as Medidata Rave, including experience with Rave EDC Custom Function programming.
• Experience with clinical research and database development within the pharmaceutical industry, as well as Agile methodologies.
• Proficiency with database structures and programming languages.
• Expertise in eCRF design and specifications development.
• Experience writing, programming, or configuring data validation checks.
• Familiarity with QC, UAT, platform testing, and creating and executing test scripts.
• In-depth understanding of the Drug Development Process, Software Development Life Cycle, Computer Validation Process, FDA regulations, ICH-GCP, and other relevant Health Authority Guidelines.
• Extensive experience with clinical data development, validation, execution, maintenance, and documentation, particularly for regulatory submission.
• Proven experience in leading system selection and implementation projects.
• Knowledge of systems outside of data management, such as safety systems, Clinical Trial Management Systems (CTMS), and electronic patient-reported outcome tools.
• Strong verbal and written communication skills, with the ability to collaborate effectively across multiple disciplines and regions.
• Extensive technical experience in developing scalable processes and solutions.
• Strong organizational skills and the ability to prioritize work to meet deadlines.
• Excellent interpersonal and project management skills, with the ability to collaborate effectively with individuals at all levels and from diverse backgrounds.
• Familiarity with JReview and Business Objects.

Preferred Qualification:

• Familiarity with other Medidata modules (e.g., CTMS, RTSM, TSDV, Coder, Lab Admin) and their integrations.
• Understanding of relational databases and data capture standards (e.g., CDSIC/CDASH).
• Advanced computer skills, including proficiency in MS Office (Word, PowerPoint, Excel, Outlook), with the ability to manage complex data analysis and pivot tables.
• Strong quantitative and analytical skills, with excellent critical thinking and problem-solving abilities.
• Ability to manage multiple technical projects and provide training to team members.
• Capacity to learn new technologies quickly and disseminate information effectively.
• Ability to innovate and transform current industry practices into more efficient solutions.

Working Environment

• This position is remote and is based in Canada.
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. 

Salary Range: $110,000-$160,000 CAD annually per year (final compensation will be determined based on a variety of factors, including but not limited to proficiency levels and organizational equity considerations)

*The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time and national holidays
• Registered Retirement Savings Plan Program (RRSP)
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Wellness programs

Astellas may use artificial intelligence-enabled tools at various stages of the recruitment and selection process.

Additional Information

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.