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Senior Data Manager (Home-Based)

Company: The Emmes Company, LLC
Location: Rockville
Posted on: September 4, 2020

Job Description:

The Emmes Company, LLC is searching for a Senior Data Manager based out of our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. 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. Primary Purpose 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 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. 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 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, manages data quality metrics for a protocol or project Attends and contributes to project and functional group 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: Collaboratively conducts performance and compensation review activities with the applicable project leader or designee Responsible for addressing employee relations issues and resolving problems Ensures DM salary and bonus equity compliance Approves timesheets, expense reports, and leave requests Required Experience Bachelor's degree in scientific discipline preferred with a working knowledge of the clinical/scientific terminology and methods; and at least 6 years progressive experience, or Master's degree and 4 years progressive experience working in a clinical research environment Basic understanding of the clinical development and data management processes; or equivalent combination of education and experience Required Skills/Abilities Knowledge of MS Excel, Word, Access, and PowerPoint Proven data management skills Excellent verbal and communication skills Self-motivated, reliable team member Strong attention to detail and flexible CONNECT WITH US Follow us on Twitter - EmmesCRO Find us on LinkedIn - The Emmes Company, LLC 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.

Keywords: The Emmes Company, LLC, Rockville , Senior Data Manager (Home-Based), Executive , Rockville, Maryland

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