Assoc Dir Clinical Data Operations

Role Summary

The Associate Director of Clinical Data Operations leads strategic vision and execution of clinical data operations, overseeing the clinical data lake, data management reporting, analytics and workflow automation. Responsible for developing regulatory-compliant data solutions to advance departmental objectives and enable high-quality clinical data. Provides operational leadership across data lake processes, data reporting, and analytics workflows to ensure high-quality execution and team performance. Designs, implements, and manages data lake solutions and standardized clinical data models (CDISC SDTM/ADaM) aligned with global regulations; supports data governance, process optimization, and workflow automation in line with GxP and regulatory requirements.

Responsibilities

• Implement the vision and strategy for the Clinical Data Lake, ensuring alignment with departmental objectives and adherence to Good Clinical Practice (GCP) principles.
• Collaborate with business stakeholders and systems teams to understand clinical research needs and establish a comprehensive data lake solutions roadmap, prioritizing high-value capabilities.
• Oversee the design, development, and implementation of the Clinical Data Lake, ensuring seamless integration with existing systems and processes.
• Lead the design and implementation of standardized data models to harmonize and integrate data for analytics and reporting.
• Lead efforts to build and maintain robust data pipelines from diverse sources including EDC systems, vendor labs, Biomarker data, electronic health records (EHR), and other healthcare datasets.
• Drive strategies for advanced data capabilities, including analytical layers and visualization tools to support clinical decision-making.
• Ensure the security, privacy, and compliance of clinical data by implementing robust access controls, encryption protocols, and audit trails in alignment with global regulatory standards such as GDPR, HIPAA, and ICH-GCP.
• Ensure alignment of clinical data structures and deliverables with CDISC standards (SDTM, ADaM) and maintain compliance with global regulatory requirements.
• Develop and maintain metadata management practices and data lineage tracking to ensure data integrity and transparency.
• Maintain inspection readiness of the Clinical Data Lake solutions by maintaining robust operational controls, documentation, and consistent adherence to GxP regulations across all clinical data workflows.
• Partner with other data lake initiatives to promote efficient operating models, domain sharing, and reuse of data assets to minimize redundancy.
• Direct and develop team members through clear expectations, performance management, and disciplined execution across all operational workflows.
• Manage matrixed teams focused on data ingestion, quality, transformation, standardization, and visualization to deliver high-value data solutions.
• Stay updated with emerging technologies, best practices, and regulatory changes in clinical data management to ensure organizational innovation.

Qualifications

• 10+ years of experience in data management, data engineering, or clinical operations, with at least 5 years in a leadership role.
• Experience managing large-scale data lake solutions, preferably in the healthcare or clinical research domain.

Skills

• Strong understanding of clinical trial processes, data standards (CDISC, SDTM, ADaM), and regulatory requirements.
• Expertise in big data technologies such as Spark, AWS, or Google Cloud.
• Proficient in clinical data integration and workflow automation, with strong capabilities in analytics, reporting, and visualization tools.
• Proficient in database management (SQL, NoSQL) and ETL tools.
• Deep understanding of scientific and clinical data collection and management platforms, including EDC, Real World Evidence, Biomarker, and other external data.
• Strong knowledge of data aggregation tools and the ability to translate findings into actionable insights that drive downstream operational activities.
• Proven ability to integrate data from diverse sources, ensuring seamless data flow, consistency, and reliability across operational and analytical environments.
• Ability to analyze and resolve complex clinical data systems and integration challenges with scalable and sustainable solutions.
• Strong analytical, problem-solving, project management, and stakeholder management skills.