This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
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
#J-18808-Ljbffr
Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.