The Emmes Company, LLC is searching for a Data Manager/Protocol Monitor located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for office location 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 Mid-Level Data Manager/Protocol Monitor (DM/PM) is responsible for completing study-specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The DM/PM works as an integral part of a multidisciplinary project team through the lifecycle of the clinical study, from study design through final analysis. The DM/PM produces study materials to ensure the appropriate data are collected and is responsible for the completeness and accuracy of the study data. Data management deliverables include data collection forms, electronic case report forms, data queries, manuals of procedure, and/or data collection guidelines. The DM/PM also performs quality control of data utilized in safety and analysis reports.

An experienced DM/PM will be expected to apply previous experience with database design (either clinical or non-clinical) to quickly learn Emmes' proprietary systems for eCRF development and query generation. An experienced DM/PM is also expected to work independently to extract required data collection elements from the protocol to develop data collection forms, develop supplemental study documents, and coordinate study report generation. The ideal candidate will be detail-oriented, a team player, a clear communicator, and able to multi-task.

Responsibilities

• Work in a team environment to design, develop, and manage clinical trial data systems, utilizing critical thinking and strong data management and computing skills
• Collaborate with Project Manager to ensure deliverables are of the highest quality
• Develop data collection forms, manual of procedures, and other supplemental study documents based on the study protocol and project standards
• Critically review study materials, such as protocols, MOPs and study specific guidelines
• Design, build, test, and validate electronic case report forms (eCRFs)
• Develop, generate, manage, and distribute data queries and reports to clinical sites
• Coordinate report generation and contribute to the quality and accuracy of reports for the duration of the trial
• Assist in the planning, monitoring, and coordination of clinical research studies at external sites by facilitating effective communications (oral and written) with internal and external project team members, site study coordinators and investigators, and the study sponsor to ensure compliance with protocol and overall clinical objectives
• Ensure adherence to project and corporate standard operating procedures (SOPs), as well as federal and ICH guidelines in maintaining data integrity and quality throughout a clinical study
• Contribute to and comply with project standardization efforts
• Duties may include medical writing, as well as planning and implementing QC steps, such as checking tables, figures, and listings; verifying data entry; reviewing data files; and reconciling text and tables

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)
• Experience translating data needs into effectively written requirements for database design
• Experience identifying and applying data querying criteria to clean complex datasets
• Strong attention to detail is required
• Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
• Ability to quickly learn and apply new software packages
• Skills in prioritization, problem solving, organization, decision-making, time management, and planning
• Ability to work effectively both independently and in a team-based environment
• Ideal candidate will be receptive to direction and feedback from others on their team
• Ideal candidate will be self-motivated, demonstrating initiative and critical thinking skills in managing daily tasks and identifying process improvements

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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.