Data Manager/Protocol Monitor

Location
Rockville, Maryland
Posted
Jun 08, 2018
Closes
Jun 11, 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 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. Emmes is seeking a Data Manager/Protocol Monitor

Project

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders. The NHLBI is convening a Cure Sickle Cell Disease Initiative (CSCI), aimed at finding innovative ways to support discovery and development of efficacious genetic therapeutic approaches and bring them to scale in clinical populations to accelerate finding curative treatments for Sickle Cell Disease (SCD). The NHLBI is working with The EMMES Corporation to establish a Coordinating Center (CC) for the CSCI and to engage key staff of this initiative.

Responsibilities

  • Preparation and follow up with project activities (call, web seminars, workshops, symposiums)
  • Attend and participate in weekly internal staff meetings for project updates and tasks assignments
  • Attend and participate in scheduled project sub-committee calls with NHLBI
  • Attend project Executive and Governance Committee calls with NHLBI
  • Attend scientific meetings on behalf of the project
  • Assist in the preparation of project conference calls and meeting minutes. Contribute in writing call and meeting minutes and follow up on action items
  • Assist in the preparation of project-required reports
  • Assist in writing, editing, and tracking project-related publications
  • 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 the project
  • Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management and computing skills
  • Develop and manage common data elements for Sickle Cell Disease
  • Design, build, test and validate electronic case report forms (eCRFs)
  • Assist in processing project applications for manufacturing requests

Experience

    Bachelor’s degree in scientific discipline preferred Minimum 2 years’ experience in clinical research, biological/laboratory sciences or related fields preferred Prior knowledge of cellular & genetic therapy is a definite plus Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful 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

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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