Data Manager (Entry-Level)

Location
Rockville, Maryland
Posted
Dec 12, 2018
Closes
Dec 20, 2018
Function
Management
Industry
Science
Hours
Full Time

The Emmes Corporation, established in 1977, is a privately-held, woman-owned private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, 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 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 searching for two Data Managers to support an AIDS Malignancy Consortium project, and can be located in our Frederick or Rockville offices.

Project

This position will provide data management support for studies on the AIDS Malignancy Consortium (AMC) research team. The AMC group focuses on innovative Phase I through III clinical trials for AIDS-related cancers. The AMC’s mission is to investigate new treatment and prevention interventions for malignancies in people living with HIV. The AMC group provides support for more than 20 clinical research studies both domestically and internationally. The AMC is a full service project that provides multi-faceted support such as data management, protocol monitoring, adverse event review and reporting, protocol development, and regulatory document tracking and submission.

The Data Manager is responsible for completing study and site specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The Data Manager works as an integral part of a multidisciplinary team through the lifecycle of the clinical study from study design through final analysis and study closeout. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database. Data management deliverables include electronic case report forms, data integrity checks, data collection guidelines, and user’s guides. The Data Manager also performs quality control of study-specific reports.

Responsibilities

  • 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)
  • 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
  • Develop site training materials and train site personnel on the EDC system
  • Participate on conference calls with site staff to review data entry progress and provide ongoing training on study procedures
  • Serve as the primary contact for a subset of clinical sites
  • 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 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 preferred Excellent oral and written communication skills Skills in prioritization, organization, and time management High attention to detail, ability to multi-task, and be 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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