[Hiring] Clinical Data Manager @Emmes Group

Role Description

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.

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.

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 2 years of data management experience (or Master’s degree) and basic understanding of the clinical development and data management processes.
• Experience in clinical electronic data capture (EDC) systems preferred.
• 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.

Benefits

• 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 December 31, 2026.
• 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.