Data Manager/Protocol Monitor

Location
Rockville, Maryland
Posted
Aug 15, 2018
Closes
Aug 23, 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 a Data Manager/Protocol Monitor

Project

The Macular Telangiectasia Project (MacTel) is an international clinical trials group to support innovative trials for macular telangiectasia. MacTel is composed of over 20 Clinical Trials Sites worldwide. Retinal telangiectasis refers to a group of uncommon, idiopathic, retinal vascular abnormalities affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula with or without vascular changes in the retinal periphery. The condition is characterized by slow vision loss beginning at adulthood that becomes progressively debilitating, but rarely leads to total blindness. The pathogenesis of macular telangiectasia is unknown. At present, there are no known treatments to prevent, ameliorate, or slow the progression of the disease.

Emmes serves as the Coordinating Center for the Natural History Study, the Extension of the Phase I and Phase II trials, and the Phase III international multi-center clinical trial to assess the safety, tolerability, and efficacy of Ciliary Neurotrophic Factor (CTNF), a class of molecules that has been demonstrated to slow the loss of photoreceptor cells during retinal degeneration. These studies involve implanting a capsule into the vitreous of the eye that secretes the CNTF, thus making the molecules available to the photoreceptor cells of the retina.

Responsibilities

  • Work in a team environment to maintain the Emmes eClinical data capture system and CRFs
  • Develop, generate and manage data queries using Integrity
  • Assist in the planning, monitoring, and coordination of the 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
  • Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP guidelines in maintaining data integrity and quality throughout the study period
  • Contribute to and comply with standardization efforts
  • Contribute to the quality and accuracy of various types of clinical study reports for the duration of the studies
Experience

    Bachelor’s degree in a scientific discipline preferred Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful Prior experience in clinical research, specifically Ophthalmology preferred Excellent oral and written communication skills Skills in prioritization, organization, and time management High attention to detail, ability to multi-task and collaborative

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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