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Clinical Data Programmer

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Date: Jun 12, 2021

Location: Rockville, MD, US

Company: NTT DATA Services

Req ID: 127005 

NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Clinical Data Programmer to join our team in Rockville, Maryland (US-MD), United States (US).

NTT DATA is seeking a highly motivated, flexible, organized, and detail oriented Clinical Data Programmer to join our dynamic team at Rockville, MD. If you want to learn, grow, and help then this is the job for you. What you do matters and has significant impact on the medical, health and scientific communities we serve. Your work here really matters and has real impact.

 

The Clinical Data Programmer will be part of the data management and programming team that helps the National Institute of Allergy and Infectious Diseases study and test new drug regimens and vaccines for emerging and re-emerging pathogens. He/she will work with international clinical research study teams and will be engaged in a variety of tasks that will be involved in the delivery, and support of clinical databases.

 

Responsibilities

 

  • Responsible managing a clinical study with moderate guidance as well as monitor the progress of clinical data management activities.
  • Review protocols for appropriate data capture tools including Case Report Form (CRF) design.
  • Interact with Investigators, data entry/review team members, programmers, study managers and statisticians in designing CRFs (and eCRFs) and creating the annotated CRF and CRF completion guidelines.
  • Plan and coordinate database design, development, implementation, maintenance, and user support of clinical data management systems.
  • Program, test, and document databases in accordance with programming standards and validation procedures.
  • Develop/test data edit check specifications and run data listings as required
  • Develop the Data Management Plan for a clinical study.
  • Enter data queries into the Clinical Data Management System to be resolved at investigational sites and manage the resolution of those queries.
  • Perform database lock and freeze activities per SOPs.
  • Participate in regular team meetings, provide data management operational status updates as well as other input when appropriate.
  • Work with study teams to define requirements to create the database schema and to implement quality control programming and edit checks.
  • Provide programming support for clinical data management and reporting for clinical studies.
  • Generate and maintain all required documentation, including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding setup, edit check procedures, import/export setup, and processing
  • Will also promote staff training and development; and is responsible for general system administration and service quality management.
  • Builds effective working relationships with team members.
  • Must be self-motivated and adaptable to learning and understanding new technologies.
  • Must be able to prioritize and manage multiple tasks to meet aggressive deadlines.
  • Must have strong analytical, problem-solving, and decision-making capabilities.
  • Must have the ability to work both independently and in a team environment.
  • Must be flexible to change and have the ability to work in a fast-paced environment.


Job Requirements

  • At least 3 to 5 years of experience with Clinical Data Management experience, programming proficiency in Electronic Data Capture (EDC) and data reporting, and/or transformation languages
  • Experience with regard to the application of CDISC standards to clinical research databases.
  • At least 3 to 5 years of experience biomedical research projects, specifically with clinical trials.
  • Must have great customer service and interfacing with customers experience required.
  • Excellent oral and written communication skills.
  • Proficiency in MS Outlook, Word, Excel, PowerPoint and Sharepoint
  • Must know and understand the application of 21 CFR Part 11 regulations within clinical research.
  • Must know and understand the application of Good Clinical Practices.
  • Prefer BS/BA degree in computer science, statistics or related field, and nominal experience, particularly in clinical programming and relational database development, or equivalent education and experience.
  • Applicants selected will be subject to a Public Trust background security investigation and may need to meet eligibility requirements for access to sensitive information.
  • SAS and/or R programming skills will be preferred.
  • US Citizens or Permanent Residents only.

 

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About NTT DATA Services

NTT DATA Services is a global business and IT services provider specializing in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services. We are part of the NTT family of companies, a partner to 85 % of the Fortune 100.

NTT DATA Services is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, gender, disability, age, veteran-status, sexual orientation, gender identity, or any other class protected by law.


Nearest Major Market: Washington DC

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