Lead Clinical Data Management, Clinical Data Management

Role Overview

• Provide leadership for clinical data management activities across multiple oncology studies and development programs.
• Serve as the senior Data Management representative on cross-functional program teams and contribute to strategic development planning.
• Define and implement data management strategies that support efficient study execution, regulatory compliance, and submission readiness.
• Lead the design and development of eCRFs, database builds, edit checks, derivations, data review plans, and study-level data management documentation.
• Ensure effective integration, reconciliation, and quality oversight of external data sources including laboratory, imaging, ePRO, genomic, biomarker, and safety data.
• Drive data quality initiatives and ensure timely resolution of data issues through proactive review, risk-based approaches, and operational metrics.
• Lead database lock planning and execution activities and ensure delivery of high-quality datasets supporting statistical analysis and regulatory submissions.
• Ensure compliance with CDISC standards, ICH-GCP requirements, applicable regulations, SOPs, and industry best practices.
• Serve as the Data Management representative on regulatory inspections, audits, due diligence activities, and health authority interactions related to clinical data management.
• Drive continuous improvement initiatives, standardization efforts, and implementation of scalable data management processes across the portfolio.
• Lead evaluation and adoption of AI-enabled technologies, automation platforms, and advanced analytics solutions that improve data quality, operational efficiency, query management, and risk detection.
• Establish governance and best practices for responsible use of AI-assisted data review and automated workflow solutions within clinical development.
• Contribute to department strategy, resource planning, talent development, and organizational objectives established by the Head of Clinical Data Management.

Requirements

• Degree in Life Sciences, Data Science, Computer Science, Biostatistics, or related discipline; advanced degree preferred.
• 10+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience leading data management activities across multiple clinical development programs.
• Strong expertise with Medidata Rave EDC, database design, external data integration, database lock processes, and clinical data lifecycle management.
• Deep knowledge of CDISC standards, including CDASH and SDTM, and their application within global development programs.
• Experience managing CROs, external vendors, and complex data streams including imaging, laboratory, ePRO, genomic, and biomarker data.
• Experience supporting health authority submissions, inspections, and audit activities.
• Experience implementing process improvement, automation, and operational excellence initiatives.
• Understanding of AI-assisted data review, automation technologies, and advanced analytics applications within clinical development.
• Excellent leadership, communication, collaboration, and strategic thinking skills.

Tech Stack

• Google Cloud Platform

Benefits

• Continuous learning opportunities
• Environment promoting teamwork and ethics
• Opportunity to make a global impact in healthcare