Director of Clinical Data Management & CRO Oversight

Jobtailor; San Diego (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

Avenzo is seeking an accomplished data management leader to provide leadership and oversight of outsourced Clinical Data Management activities across its clinical development programs.

The role serves as Data Management representative on cross-functional study teams; oversees CROs and vendors; ensures data quality and regulatory standards; drives continuous improvement across data management processes.

Qualifications

• 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
• 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

Responsibilities

• 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

Skills

Clinical Data Management

CRO Oversight

Regulatory Compliance

Data Quality Standards

Team Leadership

Vendor Governance

EDC Systems

FDA/EMA/CDISC

Risk Management

Data Lifecycle Management

Education

Bachelor's degree in life sciences/data science/computer science

Tools

EDC Systems

Clinical Data Systems

Job description

Avenzo is seeking an accomplished data management leader to provide leadership and oversight of outsourced Clinical Data Management activities across its clinical development programs.

The role serves as Data Management representative on cross-functional study teams; oversees CROs and vendors; ensures data quality and regulatory standards; drives continuous improvement across data management processes.