Summary:

The Associate Director, Clinical Data Management (CDM) will provide hands-on support for the execution of clinical data management activities across our clinical programs, from study start-up through study closeout, ensuring high quality data deliverables. This is a hands-on position that will include supervising additional CDM resources at Vaxcyte, based on the number of clinical trials in development. The Associate Director, Clinical Data Management will be responsible for the oversight and management of our Biometrics partners related activities conducted for clinical trials conducted by Vaxcyte, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and within budget.

Essential Functions:

Supports the oversight for the execution of data management for all programs and studies; accountable for data management activities for a program.

• Clinical Data Management Strategy
  • 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.
• Study-Specific Data Management
  • 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. 
• Cross-functional Collaboration
  • 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

Requirements: 

• 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.
• Familiarity with emerging technologies in clinical research, including AI/ML applications is a plus.
• Excellent project management, communication, and problem-solving skills.
• CCDM is strongly preferred