Clinical Data DevOps Lead

Overview

Lead the DevOps backbone for AstraZeneca's clinical data products, ensuring data is assembled, transformed and published to CDISC standards and used to power risk-based study monitoring.

What you'll do

• Operate, improve and scale data solutions for clinical trials across EDC, data review/monitoring and visualization, aligned to CDISC and risk-based monitoring strategies.
• Ensure adherence to IRT and IT standards; apply ICH-GCP and 21 CFR Part 11; review study team cases and provide final go/no-go decisions for custom functionality.
• Monitor and drive system change requests end-to-end, ensuring changes follow lifecycle and risk guidelines; lead outage calls and communications through to resolution.
• Advise study teams, partners and vendors on clinical data product design and support throughout the study lifecycle; guide preparation of system specifications and documentation.
• Own day-to-day application operations; identify and troubleshoot issues; create and maintain Knowledge Base Articles.
• Establish standard processes for secure coding, CI/CD, test automation and cloud operations; create and refine Epics/Stories in JIRA and prioritize with product leadership.
• Design and deliver integrations between on-prem and SaaS platforms using APIs, MuleSoft and SnapLogic; optimize data mapping, reporting and analytics using SQL and R/Python.
• Collaborate with internal teams and third-party suppliers to define requirements and implementation plans; ensure delivery meets expectations and drives measurable outcomes.
• Lead application enhancements and upgrades; improve platform resilience, performance and usability; support global library maintenance where applicable.
• Build and support analytics and visualizations (Spotfire, Qlik, Tableau, J-Review, Cognos) that power proactive data review, clean patient tracking, missing pages, third-party reconciliation and data quality checks.

What you'll need

• Bachelor's or master's degree in computer science or life science related rigor, with IT/CRO/Pharma experience.
• Total of 15 years of experience.
• Minimum 7-8 years working experience in clinical data management, clinical data analytics and visualization.
• Accredited certifications from SCDM/ACDM or any vendor offered data management trainings.
• End-to-end familiarity with clinical trial development processes and associated system landscape.
• Strong experience in implementation and maintenance of EDC (such as RAVE, Inform, Veeva) and coordination of Monitoring and Visualization Analytics Applications.
• Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics and reporting.
• Analytical and technical skills and experience with analytic software applications (i.e., Spotfire, J-Review, Qlik, Tableau).
• Experience working with EDC, IRT, third party data handling and another clinical systems implementation.
• Experience in clean patient tracker, data review, missing pages, data quality checks, 3rd party data reconciliation and business intelligence tools like Cognos, Oracle BI, Tableau, Spotfire, QlikView, Informatica.
• Excellent understanding of common industry standard business practices as related to clinical trials (study set up, clinical operations, data management and reporting).
• Knowledge of relational databases and experience using multiple clinical data management systems.
• Knowledge of general medical coding in the pharmaceutical/biotechnology industry, including medical dictionaries, coding tools and coding governance models.
• Solid understanding of CDASH, SDTM, SEND or ADaM, and CDISC controlled Terminology in context of clinical data.
• Solid understanding of clinical trial terminology and Architect Loader Specification.
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology and software development lifecycle activities.
• Expertise and/or experience in specialized analysis and reporting standards development (e.g., clinical coding, clinical dictionaries, and data analysis and reporting capabilities).
• Experience with external vendors and CROs to support Standards or EDC integrations with third party platforms (Central Lab, ePRO, IRT, Data Review/Monitoring, etc.).
• Expertise and engineering attitude to help design and implement Clinical Data Solutions adhering to Products on Platform Strategy.
• Confirmed ability to handle diverse collaborators and ensure delivery to a high degree of satisfaction.
• Shown ability to work independently in a dynamic, fast-paced environment.
• Ability to communicate confidently and lead customers, from technical personnel to senior stakeholders, in urgent or critical situations.
• Knowledge of identity management solutions based on AZURE, OKTA, OAuth, Ping Federate/AD technologies.
• Understanding of database concepts and ability to use data to optimize reporting, data mapping and programming.
• Expertise in SQL, and R and/or Python for data analysis and visualization.
• Experience in development of interfaces/integrations between on-premises and SaaS platform-enabled products using APIs, Web Services (MuleSoft) and ETL (SnapLogic).
• Some knowledge of using/creating build tools and CI/CD (maven, ant, gradle, Sonar or similar tools).
• Experience with cloud platforms such as AWS and Azure.
• Proven background in using JIRA, Confluence, Bitbucket and automated testing tools.
• Experience of working in agile teams using methodologies such as SCRUM and SAFe.
• Experience programming in Java or other object-oriented programming languages.
• Experience delivering or developing workshop material, training, gap analyses, or requirements gathering sessions with business and system collaborators.
• Certification in IT delivery framework, Scrum Master or DevOps Lead role.

Nice to have

• Clinical data programming experience.
• EDC build (Rave)/Inform and global library maintenance support experience.

Details

• Location: Chennai, Tamil Nādu, India.