Data Manager/Protocol Monitor

Location
Rockville, Maryland
Salary
Competitive
Posted
Jun 11, 2019
Closes
Jul 11, 2019
Ref
2125
Function
Management
Industry
Science
Hours
Full Time
Emmes, established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland; Fairfax, 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 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 a Data Manager/Protocol Monitor

Primary Purpose

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
  • 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 to ensure compliance with protocol and overall clinical objectives
  • Prepare scientific minutes for external distribution
  • Work in a team environment to 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
  • Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study protocol


Experience
  • Bachelor's degree in a scientific discipline or equivalent experience
  • 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


CONNECT WITH US!!

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Find us on LinkedIn - The Emmes Company

Visit us on the web - www.Emmes.com

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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