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.
This position is based in Bangalore, India. We recognize the importance of work-life balance and 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 checksets, 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 maintain product data and associated automated jobs. • Oversee and support the development of APIs interfaces and middleware solutions for seamless communication and data exchange between clinical software systems and databases. • Lead or participate 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. • Assist organizations in staying ahead of data trends and discover new ways to use product data.