Director, Data Management

• Provide leadership and oversight of outsourced Clinical Data Management activities across Avenzo's clinical development programs
• Serve as a Data Management representative on cross-functional study teams throughout study planning, execution, analysis, and reporting
• Oversee Data Management CROs and third-party vendors, including performance management, issue escalation, risk mitigation, and milestone delivery
• Oversee database build, data review, external data reconciliation, query management, and database lock activities
• Establish and maintain data quality standards, oversight plans, metrics, and processes
• Identify, assess, and manage data-related risks affecting study timelines, data quality, or regulatory deliverables
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Clinical Pharmacology, Medical Writing, Regulatory Affairs, and Quality
• Ensure high-quality clinical data supports interim analyses, DSMB reviews, regulatory submissions, and final study reporting
• Lead data review and cleaning strategies and oversee vendor deliverables and issue resolution
• Support inspection readiness, including documentation, vendor oversight records, and data management deliverables
• Ensure compliance with ICH-GCP, CDISC standards, internal SOPs, and applicable regulatory requirements
• Oversee implementation and effective use of EDC and related clinical data systems
• Support evaluation of new technologies and process improvements
• Drive continuous improvement to enhance Data Management efficiency, quality, scalability, and consistency
• Communicate study status, metrics, risks, and mitigation plans to cross-functional teams, governance committees, and senior leadership
• Build, mentor, and develop Data Management staff and contribute to talent acquisition, onboarding, succession planning, and employee development
• Foster collaboration, accountability, quality, and continuous improvement across the Data Management function

Requirements

• Bachelor's degree in life sciences, data science, computer science, or a related field required, or equivalent combination of academic and industry experience
• 10+ years of progressive clinical data management experience in the life sciences industry
• Experience leading outsourced Clinical Data Management activities and providing strategic oversight of CROs and third-party vendors
• Experience managing complex, global clinical trials and partnering with cross-functional stakeholders in a matrixed environment
• Experience building, leading, mentoring, and developing Data Management teams; prior people management experience preferred
• Strong understanding of clinical development processes and experience supporting Phase I through Phase III clinical trials and global development programs
• Deep expertise in vendor governance, performance management, and risk-based oversight of outsourced data management models
• Comprehensive knowledge of clinical trial data lifecycle management, including database design, data review, external data reconciliation, and database lock activities
• Thorough understanding of FDA, EMA, ICH-GCP, and CDISC requirements and standards
• Ability to identify and proactively mitigate operational, quality, and data integrity risks across multiple studies and programs
• Strong strategic thinking, organizational, and problem-solving skills
• Excellent leadership, communication, and stakeholder management skills
• Ability to build alignment, drive decisions, and influence outcomes without direct authority
• Experience leading process improvement, technology adoption, and operational excellence initiatives
• Excellent communication and interpersonal skills
• Strong analytical and problem-solving abilities
• Periodic/regular travel, including up to 10% of work time, with possible overnight travel
• Remote employees expected to travel to and work from the Company's San Diego headquarters from time to time; San Diego-based employees must work on-site Monday through Thursday

Core Competencies

Demonstrates extensive expertise in Clinical Data Management, including oversight of CROs, data quality standards, and compliance with regulatory requirements. Proven ability to lead cross-functional teams, manage complex clinical trials, and drive continuous improvement initiatives.

Highest-signal resume keywords

• Clinical Data Management
• CRO Oversight
• Regulatory Compliance
• Data Quality Standards
• Team Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Trial Data Lifecycle Management
• Database Design
• Data Review
• External Data Reconciliation
• Database Lock Activities
• Risk Mitigation
• Performance Management
• Process Improvement
• Technology Adoption
• Strategic Oversight

Soft Skills

• Leadership
• Communication
• Stakeholder Management
• Organizational Skills
• Problem-Solving

Industry Keywords

• ICH-GCP
• CDISC
• FDA
• EMA
• Life Sciences
• Clinical Development
• Global Clinical Trials

Tools & Technologies

• EDC Systems
• Clinical Data Systems