Manager Clinical Data Innovation

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

This position is based in Bangalore, India. We recognize the importance of work/life balance & believe in optimizing the most productive work environment for all employees to succeed and deliver.

This position is based in Bangalore, India. We recognize the importance of work/life balance & believe in optimizing the most productive work environment for all employees to succeed and deliver.

Purpose And Scope

The Manager, Clinical Data Innovation role serves the purpose of fostering innovation and operational efficiency through the facilitation of data-driven decision-making processes, expediting drug discovery initiatives, and bolstering regulatory compliance efforts. This role is critical for managing regulatory information utilizing IDMP requirements as a baseline. It involves building a system landscape that unlocks the potential of data, wherein MDM provides a centralized repository for up-to-date regulatory information. It also involves overseeing the integration and management of various clinical data and data sources throughout the various stages of clinical trials.

Through close collaboration with data owners, data consumers, and DigitalX professionals, this role establishes and upholds robust data exchange and governance frameworks that align harmoniously with business objectives, regulatory mandates, and industry standards. This role will function as the system owner for assigned systems, with the responsibilities of decision making on the system changes and budgeting. This is a strategic position in advancing the life sciences companys mission by using data to drive scientific progress, improve patient outcomes, and efficiently and securely introduce ground-breaking therapies to the market.

Responsibilities And Accountabilities

• Support the development and maintenance of comprehensive architecture strategies tailored to the needs of managing and transferring clinical trial data, from research and collection to submission.
• Research and implement innovative data technologies and methodologiesfor Master Data Management and Data Quality (e.g. Reltio, Data Quality checks etc.)
• Develop and implement data strategies to ensure the accuracy, integrity, and security of clinical data.
• Provide technical support and guidance to users as needed.
• Collaborate closely with other DigitalX team members and data professionals to integrate assigned systems or environments with other systems and workflows, ensuring a smooth and controlled flow of data.
• Support designing scalable architectures to track and maintainproduct data and associated automated jobs.
• Oversee and support development of APIs, interfaces, and middleware solutions for seamless communication and data exchange between clinical software systems and databases.
• Lead or take part in projects related to system upgrades, migrations, or new implementations.
• Liaise with software vendors and service providers to address issues, manage licenses, and support negotiate contracts.
• Actively participate in or lead Agile activities, including backlog grooming, using Azure DevOps Services.
• Stay updated on industry guidelines (e.g. IDMP compliance) and advancements to recommend and implement new tools and practices.
• Responsible for Data Quality (DQ) business rules implementation, DQ Analysis, and DQ Remediation activities.
• Identify, document and track DQ violations and defects, work with development, data lake teams to resolve issues.
• Assistorganizations stay ahead of data trends and discover new ways to useproduct data.
  
  

• Bachelor of Science degree in Computer Science, Information Systems, Data Science, or a related field.
• Minimum of 5 years of relevant experience working in Master Data Management solutions and Data Quality framework within a healthcare industry.
• Deep understanding of clinical data systems, as well as related environments and tools.
• Proficient in Reltio data model configuration (Entity types, attributes), matching rules, operational values and survivorship rules, relationships, User Interface, and hierarchies.
  
  

• Master of Science degree in Computer Science, Information Systems, Data Science, or a related field.
• 5+of demonstratedexperience in Life Sciences industry.
• Knowledge of clinical/product data systems(e.g. Reltio, Databricks)and experience in system configuration, maintenance, and troubleshooting
• Proficiency in SQL and data quality tools (e.g. Talend, Databricks, Informatica Data Quality)
• Understanding of data stewardship, governance principles, and security practices to protect Astellas data and systems.
• Experience in managing projects related to system design, implementation, upgrades, or integrations.
• In-depth understanding of life sciences data and business processes, adept at translating business requirements into effective technical solutions.
• Experience with Agile method and mindset.
• Excellent verbal and written communication skills to interact with users, stakeholders, and vendors effectively.
• Project management capabilities, ensuring adherence to timelines for successful solution delivery.
• Demonstrated leadership skills, including guiding technical teams, offering mentorship, and influencing architectural decisions.
• Strong understanding of ETL/ELT processes, and cloud based scalable data storage analytics platforms such as Azure, AWS, and GCP.