Data Manager/Protocol Monitor (Entry-Level)
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 and operational 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 to support projects in its Transplant & Oncology research unit.
This position will support a commercial client project under the Blood and Marrow Transplant Clinical Trials Network, established in October 2001 to conduct large multi-center clinical trials. The project supports the implementation and management of a global, Phase III, pivotal randomized clinical trial in patients with Acute Myeloid Leukemia (AML) following a Bone Marrow Transplant (BMT). There will be around 150 sites globally and the team at Emmes is part of the Data Coordinating Center (DCC), along with two other organizations. This is a full scope project providing data management, monitoring, regulatory and statistical support.
- 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 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 Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study protocol
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 or 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.