Assoc. Dir., Data Architect Manager
PharmaPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assurancemeddragcppharmacovigilancesaspythonclinical data management
Job description
Job Description Brief Description The Associate Director leads and develops a programming and reporting team - set goals, assign work, coach performance, and manage recruiting/onboarding - while communicating status and risks to leadership and partners. Provide hands-on technical review, solutioning support, enforce SOPs/standards, manage workload and prioritization, track quality and timelines, and drive best practices (code review, reusable components, test automation) and continuous improvement. Responsibilities Programming and reporting Lead design and deployment of clinical technology system solutions (e.g., for EDC, RTSM, and eCOA/ePRO) using programming frameworks and automation tools. Provide technical oversight for clinical programming, reporting, and data integration across portfolios. Recommend and implement tools to streamline design, build, and validation processes. Apply data literacy to design transformation strategies for actionable insights. Develop advanced reporting solutions (dashboards, listings, visual analytics) with reusable components and role-based access. Data Engineering Define and govern integration architecture, including data sources and transformation workflows. Ensure consistent implementation of enterprise standards and reusable assets. Monitor and troubleshoot data ingestion and consumption for reliability. Automate and strengthen data engineering processes to reduce risk and improve efficiency. Develop robust data models, semantic layers, and curated datasets; enforce quality checks. Process Drive process optimization by identifying gaps and implementing improvements. Translate strategy into clear priorities, roadmaps, and ways of working for assigned domains. Lead testing strategies for solutions; automate validation and ensure traceability. Contribute to resource planning and workload distribution across global teams. Set documentation and audit standards; ensure compliance through rigorous change management. Lead cross-functional collaboration, meetings, and enterprise-level improvement programs. Influence adoption of data standards, tools, and automation for better delivery and decision-making. Provide leadership, coaching, and mentoring to build capabilities and foster a culture of quality and collaboration. Support release management across environments; align stakeholders, lead UAT, and improve reporting standards. Partner across teams to turn data and technical findings into clear, actionable recommendations Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery. People management Set clear objectives aligned to organizational goals; assign work and set priorities. Conduct regular check-ins and annual reviews; coach for performance; provide recognition. Help develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring. Support recruiting and hiring; manage sensitive employee-relations matters (including separations) in partnership with HR. Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans. Coordinate contingent resources across geographies; ensure role clarity and effective handoffs. Support management of an operating budget and optimize spend against priorities. Align teams around a clear direction; facilitate team/functional meetings. Embrace Enterprise Leadership Skills principles and serve as a role model to their team Drive enterprise leadership skills in the team Champions organizational change; drives adoption of new operating models and digital capabilities across global functions Support staff in the resolution of operational challenges through direct engagement, facilitation, mentoring, and strong problem-solving techniques. Technical Skills Expert-level proficiency in different technology languages (e.g., SQL, Python, SAS, and R) for implementing clinical data collectors, integrations, transformations, visualizations Evidence of experience in architecting and interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms Proficiency with key data-management and/or clinical operations tools and platforms (e.g., systems for data capture, review, visualization, reconciliation, and reporting), with the ability to help select, configure, or optimize solutions. Broad understanding of the data-management technology ecosystem (e.g., data capture, review, reconciliation, reporting, analytics, and enabling tools) and how components fit together across the end-to-end process. Experience leveraging automation, scripting, or digital solutions to streamline data-management activities and reduce manual effort. Ability to interpret operational and quality metrics, use analytical/forecasting tools for capacity and scenario planning, and translate insights into clear decisions and actions. Strong understanding of common clinical and regulatory data standards, clinilcal operational data models, metadata management, and controlled terminologies (e.g., MedDRA, WHODrug) to ensure consistency and submission readiness. Strong understanding of validation, system lifecycle, data-privacy, and System Development Lifecycle Management activities Strong understanding of drug discovery process, FDA regulations, GxP / ICH guidelines <span st
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