Vaxcyte · 16 hours ago
Associate Director, Clinical Data Management
United States
Full-time
Remote
Lead/Staff, Director/Executive
$180K/yr - $210K/yr
10+ years expVaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases. The Associate Director of Clinical Data Management will oversee data management activities for clinical trials, ensuring high-quality deliverables and compliance with regulatory standards.
BiopharmaBiotechnologyHealth Care
Responsibilities
Supports the oversight for the execution of data management for all programs and studies; accountable for data management activities for a program
Support the implementation of CDM strategies aligned with Vaxcyte’s goals and clinical research best practices, including feedback into CDM system development and optimization as well as study data collection, reviewing, and reporting
Continuously improving data management processes and workflows to increase efficiency, data quality, and team productivity
Assist in establishing clinical data standards and processes to ensure consistency and quality across all Vaxcyte studies
Help develop CDM departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs
Track department budget both for external and internal spend
Supports data management activities for regulatory submissions
Execute study-specific data management and data quality plans and support documentation (data transfer specifications, data review/reconciliation plans, database lock plans, etc.) as required across the data lifecycle for various data sources (e.g., eCOA, etc.)
Serve as a data management subject matter expert (SME) and primary point of contact
Ensure study-specific data management practices align with applicable regulatory requirements (e.g., GCP, FDA, GDPR)
Oversee the end-to-end data lifecycle across studies, including development of CRFs and CRF guidelines, database setup, data quality validation
Lead data review, including query management, and activities required for interim and final database locks, ensuring high quality
Execute operational data management plans across studies to ensure on-time delivery of all study data
Ensures data management documentation is filed/archived according to applicable company and regulatory requirements
Reviews clinical study related documents from a data management perspective (e.g. protocol) and approves data management specific documents (e.g. Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.)
Assist with tracking of status of data management related activities (e.g. EDC setup, data cleaning, coding, etc.)
Assist with final sign off of project and study-related documents including, Edit Check Specifications, CRF Completion Guidelines, Data Transfer Agreements, etc
Collaborate seamlessly with internal teams, including Clinical Operations, Clinicians, Biostatistics, Project Management, and Patient Recruitment, Enrollment, & Engagement, to ensure successful study execution
Collaborate with Quality & Regulatory and other internal/external experts (e.g., privacy, legal) to maintain compliance with relevant regulations and reporting/disclosure expectations and stay informed of evolving standards and focusing on continuous process improvement within clinical trial data management
Effectively represent data management at project review meetings, quality review meetings, and other stakeholder meetings
Assist clinical study team with the planning, preparation, and on-site support of investigators meetings and CRA trainings
Provides oversight for Biometrics, Data Management CROs, EDC, and other third-party vendors who provide clinical study data to ensure compliance with the protocol, external/internal procedural standards, GCP, applicable regulatory guidelines, company policies, SOPs and other relevant guidelines
Fostering a culture of innovation and continuous improvement in clinical data management practices
Support onboarding of new CDM employees
Qualification
Required
BA/BS in life sciences, technical or health-related field, with a minimum of 10 years of pharmaceutical industry experience or CRO with duties of varying complexity
Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements
Excellent oral and written communication skills, project and personnel management skills and organizational skills
Experience in developing, implementing, and overseeing data management plans and quality plans for multiple concurrent research studies
Experience in development of database specifications and build, CRF design, and CRF guideline design, as well as traditional clinical data management systems and/or electronic data capture (EDC) platforms
Understanding and strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes
Familiarity with CDISC standards (SDTM, ADaM, CDASH) is required
Excellent project management, communication, and problem-solving skills
Preferred
Familiarity with emerging technologies in clinical research, including AI/ML applications is a plus
CCDM is strongly preferred
Benefits
Comprehensive benefits
An equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
H1B Sponsorship
Vaxcyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
2025-12-09
Company data provided by crunchbase