Manager, Clinical Data Innovation

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 company's mission by using data to drive scientific progress, improve patient outcomes, and efficiently and securely introduce ground-breaking therapies to the market.

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.

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 methodologies for Master Data Management and Data Quality (e.g. Reltio , Data Quality checks etc.)

• Develop and implement data strategies to ensure the accuracy, inte grity, 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 d esign ing scalable architectures to track and maintain product 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 pra ctices.
• 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 .
• Assist organizations stay ahead of data trends and discover new ways to use product data.

Required Qualifications:

• 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.

Preferred Qualifications:

• Master of Science degree in Computer Science, Information Systems, Data Science, or a related field.

• 5+ of demonstrated experience 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.