Data Manager/Protocol Monitor

6 days left

Location
Rockville, Maryland
Posted
Jan 18, 2019
Closes
Jan 26, 2019
Function
Management
Industry
Science
Hours
Full Time
The Emmes Corporation is searching for a Data Manager/Protocol Monitor located in our Rockville, Maryland office. Emmes has offices located at the below locations and throughout the greater Washington, DC area with flexibility for office location preference, dependent upon position.

The Emmes Corporation, established in 1977, is a woman-owned, 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.

Project

This position will support the Blood and Marrow Transplant Clinical Trials Network, established in October 2001 to conduct large multi-center clinical trials. The purpose of the trials is to address important issues in hematopoietic stem cell transplantation to further the understanding of the best possible treatment approaches. The BMT CTN is comprised of 16 core clinical centers in the United States and a Data Coordinating Center (DCC). Emmes serves as the DCC, along with two other organizations.

Responsibilities

  • Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management and computing skills
  • Design, build, test and validate electronic case report forms (eCRFs) in Advantage eClinical
  • Develop, generate, manage, and distribute data queries and reports to clinical sites
  • Contribute to the quality and accuracy of various types of clinical study 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
  • Assist in the creation of the data system training process including the development of the training materials
  • 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
Experience

    Bachelor’s degree in a scientific discipline or equivalent experience 2 years’ experience, preferably with Blood and Marrow Transplant and/or cellular therapy clinical trials Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful Attention to detail, requirements documentation and change management are a necessity Experience in clinical research, specifically oncology and bone marrow transplant experience is a plus Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Skills in prioritization, problem solving, organization, decision making, time management and planning

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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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