Clinical Data Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 18, 2020
Closes
Nov 17, 2020
Ref
2637
Function
Management
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for a Clinical Data Manager based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for the office location preference 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.

Primary Purpose

The Clinical Data Manager is responsible for data management activities for research studies. The Clinical 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 Clinical 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
  • Help organize project team meetings and facilitate efficient project communication to ensure deadlines are met, participate in functional group 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 training for users on the EDC system and protocol specific EDC requirements, maintains training documentation and manages system user access


Required Experience
  • Bachelor's or Master's degree required (scientific discipline preferred)
  • 2+ years of experience in data management and/or database design (experience in a clinical research setting is a plus)


Required Skills/Abilities
  • Knowledge of MS Excel, Word, Access, and PowerPoint is essential
  • Ability to handle multiple tasks at one time and to work with minimal supervision
  • Excellent verbal and communication skills
  • Strong attention to detail and flexible


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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