Clinical Data Management Lead

Location
Rockville, Maryland
Posted
Dec 17, 2018
Closes
Dec 25, 2018
Function
Management
Industry
Science
Hours
Full Time

The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, 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 offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking Clinical Data Management Leads, located in either our Rockville or Frederick offices

Project

This position will support one or more studies within the Vaccine and Infectious Disease (VID) research team that provides data management and statistical support for more than 200 clinical research studies, domestically and internationally. The VID group supports infectious disease research across a wide range of disease areas, including: Malaria, Tuberculosis, Influenza, Ebola, MRSA, STI and Enteric pathogens, and emerging infectious diseases. VID supports Phase 1-4 clinical trials investigating vaccines and treatments for bacterial, viral, and parasitic agents, as well as epidemiological studies. Primary services include statistical design and analysis; bioinformatics support; implementation of Emmes’ proprietary software for electronic data collection, data management, and electronic specimen tracking; preparation of study-related materials and web site development; generation of safety, regulatory, and final reports and manuscripts; clinical site training, assessment, and technical assistance; and study communication and collaboration.

The Clinical Data Management Lead is responsible for overseeing all study-specific data management activities within their study portfolio in accordance with Good Clinical Practices and other relevant guidelines. The Clinical Data Management Lead works closely with the statistician to lead a multidisciplinary project team through the lifecycle of the clinical study, from protocol development through final reporting, and ensures deliverables are of high quality. The Clinical Data Management Lead is instrumental in the creation and/or review of data management deliverables (including data collection forms, electronic case report forms, data integrity checks, manuals of procedure, and data collection guidelines). The Clinical Data Management Lead is a primary point of contact with the study sponsor and clinical site investigators; thus, must possess strong oral and written communication skills. The ideal candidate will be organized and efficient, detail-oriented, and able to multi-task.

Responsibilities

  • Accountable for the execution and overall quality of data management activities and deliverables.
  • Act as the Emmes point of contact for the study sponsor and the collaborating investigators to initiate and support data management activities for clinical protocols
  • Provide guidance, training, and supervision to study data managers
  • Lead development of the electronic case report forms and the study database
  • Review data edit checks and queries produced by the study data managers
  • Provide critical review of study materials, including the study protocol, manual of procedures, and statistical analysis plan
  • Coordinate and contribute to generation of study reports (safety, regulatory, and final)
  • Review and contribute to manuscripts
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience with a minimum of 4 years of data management experience in clinical research OR Master’s degree in a relevant field with a minimum of 2 years of data management experience in clinical research Knowledge of Good Clinical Practices and Human Subjects Protection regulations, as they relate to data management Familiarity with Good Clinical Data Management Practices Strong data management background: experience with CRF design, EDC systems, or other web-based data collection system Demonstrated understanding of data query and reconciliation process Prior experience in mentoring/training new or junior staff is a plus Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Strong collaborator and able to work well as part of a team Skills in prioritization, problem solving, organization, decision making, time management and planning

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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The EMMES Corporation 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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