Senior Clinical Data Manager - Temp to Perm

The EMMES Corporation•Rockville, MD

5d•Remote

About The Position

Sr. Clinical Data Manager US - Remote Note for Applicants: This assignment will start you off as a temporary full-time employee working 40 hours per week. The work presently is forecasted to go till August 31, 2026. (As new data becomes available, this forecast may change.) And after that, a decision will be made if the work will continue and if so, whether or not to convert whomever is in the role to a FTE. Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The Senior Data Manager is responsible for data management oversight activities for research studies. The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Senior Data Manager is 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.

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
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
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 membe

Nice To Haves

Experience in pharmaceutical industry and/or contract research organization preferred
Experience in clinical electronic data capture (EDC) systems preferred

Responsibilities

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 departmental 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 a resource for troubleshooting system issues
Creates and/or reviews study data management documents according to instructions (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; may conduct or review data quality audits
Attends and contributes to project and department meetings; may serve as DM representative on external calls as required
Mentors staff on project-specific clinical data management processes; provides data management expertise at a project level
May provide direct line support for DM staff. For direct reports: o Collaboratively conducts performance and compensation review activities with the applicable project leader or designee o Responsible for addressing employee relations issues and resolving problems o Ensures DM salary and bonus equity compliance o Approves timesheets, expense reports, and leave requests
Other duties as assigned