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  • Date Posted:

    08/15/14
  • Career Level:

    Experienced (Non-Manager)
  • Pay Range:

    Negotiable
  • Job Function:

    Software Developer
  • Job Status:

    Full-Time
  • Industry:

    Biotech, Pharmaceutical
  • Contact Information:

    Employer Site
 
 
 
 
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Business Analyst-Clinical Systems Analyst

The EMMES Corporation - Rockville, MD

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The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. EMMES is seeking a Business Analyst-Clinical Systems Analyst to support all phases of clinical trials.  

Primary Purpose

 

The Clinical Systems Analyst is the liaison between the project team (directors, statisticians, protocol monitors, data managers) and the programming team and is the information management specialist for projects.  The Clinical Systems Analyst is responsible for managing a project’s software development life cycle and ensuring that requirements and specifications for new and existing data systems and data migrations are documented accurately and communicated to the programming group and project team. Additionally, the Clinical Systems Analyst should be familiar with the system’s capabilities, limitations, and requirements and ensure that they are clear to project staff. In situations where these appear inharmonious, the Clinical Systems Analyst is expected to work with the programming group and project staff to resolve the apparent conflict.

 

Primary Responsibilities

 

  • Manage a project’s software development life cycle for data capture applications (i.e., AdvantageEDC, GlobalTrace, etc.) from requirements gathering to end-user support.  This includes developing schedules, defining milestones, and ensuring resource availability.
  • Write and maintain thorough requirements for new and existing data systems.
  • Maintain comprehensive documentation in accordance with corporate SOPs and ensure Good Technical Practice
  • Demonstrate proficiency in development and testing of data system specifications.
  • Act as the liaison between the IT staff and project staff to ensure mutual understanding with regards to protocol workflow, technical requirements, time lines, system functionality, system capabilities, and new product developments
  • Train project staff in development and testing of data system specifications
  • Triage and manage end-user support issues for data capture systems and web sites
  • Coordinate project informational web site design and development
  • Ensure that systems security policies and procedures are maintained by the project
  • Prioritize and manage project technical issues and ensure timely completion
  • Review project information management needs and propose efficient and economical solutions
  • Provide and apply solutions to project and corporate needs
  • Demonstrate understanding of project and corporate SOPs by producing work in compliance with the SOPs
  • Maintain documentation required by corporate and project SOPs
  • Participate in internal audits and other project and corporate quality assurance activities, (e.g., participates in Internal Quality Assurance Team (IQAT) meetings)

 

Requirements

 

  • Bachelor’s degree, preferably in information systems or a health-related/scientific discipline 
  • 2-3 years clinical trial experience preferred
  • Strong computer and analytical skills.
  • Experience with system implementation or product development preferred
  • Previous experience with requirements documentation and systems testing preferred.
  • Attention to detail is a necessity
  • Technical understanding of operating system and database concepts, and application implementation and troubleshooting experience preferred
  • Knowledge of principles and methods of systems and application implementation, configuration management and maintenance, database management
  • Working knowledge of Java and SQL preferred 
  • Excellent written and oral communication skills and the ability to interact with people of all technical levels
  • Excellent interpersonal skills, especially the ability to advocate, negotiate, listen and collaborate with a variety of individuals and groups
  • Ability to work both independently and in a complex team environment
  • Ability to manage multiple tasks

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


 

*For immediate consideration please submit your resume and apply directly through the company website at www.emmes.com.


 

Please visit our website at www.emmes.com for additional information on our company, studies and history.


CONNECT WITH US!!

Follow us on Twitter - @EMMESCorp

Find us on LinkedIn - The EMMES Corporation


EMMES is proud to be an Equal Opportunity Employer EOE/M/F/D/V



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Company Profile

The EMMES Corporation

Total Employees: 350
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland, just outside of Washington, D.C., a short distance from NIH, FDA, and the Route I-270 biotechnology corridor. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.
EMMES employs a full-time staff of over 350 people. Half of our employees hold advanced degrees. One-third of that group have the highest degree awarded in their fields, typically a Ph.D. or M.D. The balance holds M.P.H., M.S., or M.S.N. degrees. The largest number of advanced degrees are in the areas of statistics, epidemiology, and in the biomedical and health related fields of cell and molecular biology, physiology, biophysics, genetics, cell and developmental biology, pharmacology, microbiology, nutrition, and psychology. Almost all of our employees hold at least a B.S. or B.A. degree in the natural or physical sciences, engineering, computer science, or business administration. Our staff includes individuals who are multi-lingual in German, Russian, Farsi, French, Greek, Spanish, Portuguese, Italian and several dialects of Chinese and Indian languages.
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Didn't find what you were looking for?

Keywords

Location

  • Date Posted:

    08/15/14
  • Career Level:

    Experienced (Non-Manager)
  • Pay Range:

    Negotiable
  • Job Function:

    Software Developer
  • Job Status:

    Full-Time
  • Industry:

    Biotech, Pharmaceutical
  • Contact Information:

    Employer Site
 
 
 
 
16
more jobs from this company
 
 
WPNI ID: 30663747