Associate Director, Clinical Data Management

4 weeks ago

Bothell, United States Medix Full time

The Associate Director of Clinical Data Management will take the lead in managing data for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director of Clinical Operations, the individual in this role will offer guidance and leadership across all stages of clinical studies, from EDC study design to study closeout. They will oversee and manage clinical data management activities that are outsourced to CROs.

Key Roles and Responsibilities:

  • Oversee Clinical Data Management activities outsourced to CROs, ensuring compliance with the scope of work and service agreements.
  • Develop Data Management metrics and key performance indicators to facilitate oversight and management of CRO partners.
  • Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
  • Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
  • Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
  • Contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs.
  • Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
  • Participate in vendor qualifications and audits.
  • Oversee planning, execution, and maintenance of major projects and initiatives, if required.
  • Lead data management study inspection readiness activities and support submission activities as needed.
  • Provide training and mentorship to DM staff or members of the clinical trial team on processes, projects, systems, and programs.
  • Perform hands-on data management responsibilities if required.

Preferred Education/Experience:

  • Bachelor's degree in science or related area (or equivalent); Master's or Advanced Degree preferred.
  • 5+ years of experience in clinical data management within the biotech/pharma industry; extensive hands-on experience in all aspects of data management.
  • Experience with global phase III clinical trials for a biotechnology company, preferably with Vaccines.
  • Familiarity with Industry Standards (e.g., CDISC) in data collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
  • Experience with Medidata Rave (EDC) and Metadata Repository (MDR) preferred.

Knowledge, Skills, and Abilities:

  • Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
  • Strong organizational skills, attention to detail, and self-motivation.
  • Experience in vendor management.
  • Proficiency in creating all components of a submission package.
  • Team player with the ability to work successfully across functions.

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