TELECOMMUTE – US National
Senior Clinical Data Manager
Position Location United States – Remote
Job Code 2735
# of openings 1
The Emmes Company, LLC is searching for a Senior Clinical Data Manager. Emmes provides flexibility for the office location or work remote preference dependent upon position.
The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India.
Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents.
We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research.
Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Senior Clinical 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 Clinical 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.
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
Work 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 solution
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,…
System Administration , Medical Research , Science