Senior Data Manager, CDE

Overview

Senior Data Manager

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Senior Data Manager, CDE is responsible for Common Data Element (CDE) and data management oversight activities for research studies. The Senior Data Manager, CDE works as an integral part of a cross-functional team through the lifecycle of the research study beginning with the design of CDEs to be used in clinical studies. The Senior Data Manager, CDE is responsible for the completeness and accuracy, quality assurance/compliance of the CDE standards and serves as the point of contact with internal and external project staff. The Senior Data Manager, CDE may also be responsible for the completeness and accuracy of the study data in the electronic database and serves as primary point of contact with internal and external project teams on all aspects of data collection.

Responsibilities

• Coordinates the development of CDEs
• Ensures communications from subject matter experts for CDE development and modifications are provided to the CDE team
• Coordinates the updates of CDEs as defined by subject matter experts
• Ensures the consolidation of disparate case report forms into a unified template
• Collaborates with cross-functional teams and facilitates the development, documentation, and configuration of CDE data standards
• Collaborates with cross-functional teams and facilitates the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system
• Creates and/or reviews study-specific electronic or paper Case Report Forms (CRFs), using prior knowledge, protocol-specific information, and department standards; works efficiently to incorporate core clinical team input and produce CRFs in a timely manner
• Determines data collection requirements based on the study protocol and system knowledge; makes recommendations based on previous experience
• Proactively identifies potential data management issues/risks and recommends/implements solutions
• Manages data collection and data validation at participating clinical sites
• Manages training documentation and provides oversight of system user access; may serve as resource for troubleshooting system issues
• Creates and/or reviews study data management documents (e.g., Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)
• Independently monitors own activities and project status for successful project deliverables according to timelines
• Manages data reports and creates data summaries or presentations as applicable
• Manages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelines
• Manages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
• Performs data review and query identification/resolution; manages data quality metrics for a protocol or project
• Attends and contributes to project and functional group meetings; may serve as DM or CDE representative on external calls as required
• Mentors staff on CDE processes and standards and on project-specific clinical data management processes; provides data management and CDE expertise at a project level
• May provide direct line support for CDE and DM staff:
• Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
• Responsible for addressing employee relations issues and resolving problems
• Ensures DM salary and bonus equity compliance
• Approves timesheets, expense reports, and leave requests
• Other duties as assigned
  
  

Qualifications

• Bachelor’s degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
• 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
• Bachelor’s degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
• 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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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.