Clinical Data DevOps Lead

GCL: E Introduction to role: Are you ready to turn complex clinical trial data into fast, trusted insights at scale? In this role, you will lead the DevOps backbone for our clinical data products, ensuring data is assembled, transformed, and published to rigorous CDISC standards and used to power risk‑based study monitoring. Your work will directly accelerate decision-making across our trials and, ultimately, benefit patients who rely on our medicines. You will join a high-performing, agile team partnering closely with Product and Platform leadership, Release Management, and Solution/Integration Architects. Together, you will set and embed guidelines in software engineering, solution design, enterprise integration, and project delivery. Do you thrive at the intersection of engineering rigor, clinical data standards, and real-world impact? Accountabilities: Platform DevOps Ownership: Operate, improve, and scale data solutions for clinical trials across EDC, data review/monitoring, and visualization to deliver reliable data capture, transformation, and publication aligned to CDISC and risk-based monitoring strategies. Standards and Compliance Leadership: 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. Change and Release Orchestration: Monitor and drive system change requests end-to-end; ensure changes follow lifecycle and risk guidelines; lead outage calls and communications through to resolution. Technical SME for Studies: Advise study teams, partners, and vendors on clinical data product design and support throughout the study lifecycle; guide preparation of system specifications and documentation. Incident and Problem Management: Own day-to-day application operations; identify and troubleshoot issues; create and maintain Knowledge Base Articles to speed incident resolution and enable self-service. Engineering Excellence: Establish standard processes for secure coding, CI/CD, test automation, and cloud operations; create and refine Epics/Stories in JIRA; prioritize with product leadership for maximum value. Integration and Data Engineering: 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. Collaborator and Vendor Partnership: Collaborate with internal teams and third-party suppliers to define requirements and implementation plans; ensure delivery meets expectations and drives measurable outcomes. Continuous Improvement and Upgrades: Lead application enhancements and upgrades; improve platform resilience, performance, and usability; support global library maintenance where applicable. Risk-Based Monitoring Enablement: 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. Essential Skills/Experience: Clinical Data Technology Domain: • Bachelor or master’s degree in computer science or life science related rigor with IT/CRO/Pharma experience with total of 15 years of experience • Minimum 7-8 years working experience in clinical data management, clinical data analytics and visualization. Experience in programming related to clinical data is a plus. • Accredited Certifications from SCDM/ACDM or any vendor offered data management trainings. • End to end familiarity with clinical trial development processes and its 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). • EDC build (Rave)/Inform and global library maintenance support experience a plus. • Knowledge of relational databases and experience using multiple clinical data management systems. • Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of 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/G guidelines, 21 CFR Part 11, clinical trial methodology and software development lifecycle activities. • Expertise and/or experience in specialized analysis and reporting standards development skills (e.g., clinical coding, clinical dictionaries, and data analysis & reporting capabilities. • Experience with external vendors and CROs to support Standards or EDC integrations with third party platform (Central Lab, ePRO, IRT, Data Review/Monitoring, etc.) IT Engineering: • Expertise and engineering attitude to help design and implement a 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. • Confidently communicate and social skills to lead customers, from techni