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Senior Data Manager

2 months ago

Rockville Maryland, United States The EMMES Corporation Full time
About The EMMES Corporation

The EMMES Corporation is a leading provider of clinical research services, dedicated to advancing public health initiatives and improving patient outcomes. Our team of experts is passionate about delivering high-quality data management solutions that meet the evolving needs of the pharmaceutical and biotechnology industries.

Job Summary

We are seeking a highly skilled Senior Data Manager to join our team. As a key member of our data management department, you will be responsible for overseeing data management activities for research studies, ensuring the accuracy and completeness of study data, and collaborating with cross-functional teams to design, implement, and validate clinical data collection systems.

Key Responsibilities
  • Collaborate with cross-functional teams to design, document, test, and implement clinical data collection studies in electronic data capture (EDC) systems.
  • Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards.
  • Determine data collection requirements based on the study protocol and system knowledge, making recommendations based on previous experience.
  • 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, serving as a resource for troubleshooting system issues.
  • Create and/or review study data management documents according to instructions.
  • 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, managing data quality metrics for a protocol or project.
  • Attend and contribute to project and department meetings, serving as a DM representative on external calls as required.
  • Mentor staff on project-specific clinical data management processes, providing data management expertise at a project level.
  • May provide direct line support for DM staff, including conducting performance and compensation review activities, addressing employee relations issues, and resolving problems.
Requirements
  • 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.
  • 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.
  • Knowledge of Microsoft Office suite is essential.
  • Proven data management skills.
  • Excellent verbal and written communication skills.
  • Self-motivated and proactive.
  • Strong attention to detail, adaptable, and flexible.
  • Reliable and collaborative team member.