Senior Data Manager

1 day ago

Rockville, Maryland, United States The Emmes Company, LLC Full time
Job Title: Senior Data Manager

Emmes Group is seeking a Senior Data Manager to join our team. As a Senior Data Manager, you will be responsible for overseeing data management activities for research studies, ensuring the completeness and accuracy of data, and serving as the point of contact for internal and external project staff.

Responsibilities:
  • Coordinate the development of Common Data Elements (CDEs)
  • Ensure communications from subject matter experts for CDE development and modifications are provided to the CDE team
  • Coordinate the updates of CDEs as defined by subject matter experts
  • Ensure the consolidation of disparate case report forms into a unified template
  • Collaborate with cross-functional teams and facilitate the development, documentation, and configuration of CDE data standards
  • Collaborate with cross-functional teams and facilitate the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system
  • Create and/or review study-specific electronic or paper Case Report Forms (CRFs), using prior knowledge, protocol-specific information, and department standards
  • Determine data collection requirements based on the study protocol and system knowledge
  • Proactively identify potential data management issues/risks and recommend/implement solutions
  • Manage data collection and data validation at participating clinical sites
  • Manage training documentation and provide oversight of system user access
  • Create and/or review study data management documents
  • Independently monitor own activities and project status for successful project deliverables according to timelines
  • Manage data reports and create data summaries or presentations as applicable
  • Manage the development of the data validation plan and ensure associated edit checks are completed in accordance with project timelines
  • Manage and reconcile data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
  • Perform data review and query identification/resolution; manage data quality metrics for a protocol or project
  • Attend and contribute to project and functional group meetings
  • Mentor staff on CDE processes and standards and on project-specific clinical data management processes
  • May provide direct line support for CDE and DM staff
Qualifications:
  • Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline
  • Incumbent typically will possess at least 6+ years of progressive data management experience (or Master's degree and 4 years) and good understanding of clinical research and/or data management processes
  • Knowledge of GCP and applicable regulatory guidelines
  • Experience in pharmaceutical industry and/or contract research organization preferred
  • Experience in clinical electronic data capture (EDC) systems preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Flexible Approved Time Off
  • Tuition Reimbursement
  • 401k Retirement Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code & Work Environment

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