Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

US - Remote

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION:
  We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH:
  We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART:
  Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE:
  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

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.

• 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…