Clinical Data Manager - Temp to Perm

Emmes Group•Rockville, MD

11h•Remote

About The Position

The Data Manager is responsible for data management activities for research studies. The 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 Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and collaborates 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
At least 2 years of data management experience (or Master’s degree)
Basic understanding of the clinical development and data management processes
Knowledge of Microsoft Office suite is essential
Ability to handle multiple tasks at one time and to work with minimal supervision
Excellent verbal and written communication skills
Strong attention to detail, adaptable, and flexible

Nice To Haves

Experience in clinical electronic data capture (EDC) systems preferred

Responsibilities

Participates with cross-functional teams in design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system
Designs and/or develops study-specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection
Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledge
Documents and resolves data management issues for a protocol or group of protocols
Assists with communication for internal and external teams to resolve data management issues
Creates or reviews data validation check specifications; coordinates with relevant parties in the development and testing of eCRF and data validation checks
Helps organize project team meetings and facilitates efficient project communication to ensure deadlines are met; participates in department meetings
Creates and maintains 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)
Prepares data reports and assists with data presentations as applicable
Reviews data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
Mentors assigned employees on data management procedures and guidelines
Identifies and resolves data queries and discrepancies; contributes to data quality metrics for a protocol or project; conducts data quality audits
Conducts training for users on the EDC system and protocol-specific EDC requirements; maintains training documentation and manages system user access
Other duties as assigned