NETE is seeking a highly motivated, flexible, organized, and detail oriented Clinical Data Manager/Database Programmer to join our team. If you want to learn, grow, and help then this is the job for you. We support a project/customer that "seeks fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.” What you do matters and has significant impact on the medical and scientific communities we serve.
The Clinical Data Manager/Database Programmer will be part of the data management and programming team. He/she will work with international clinical research study teams and will be engaged in a variety of tasks that will involve the programming, delivery and support of clinical databases intended for clinical research programs.
Responsible to lead clinical studies with moderate guidance as well as monitor the progress of data management activities. Additionally, responsible for providing regular status reporting on data management progress.
Review protocols for appropriate data capture tools including Case Report Form (CRF) design.
Interact with data entry/review team members, programmers, study managers and statisticians in designing CRFs (and eCRFs) and creating the annotated CRF and CRF completion guidelines.
Develop data edit check specifications and run data listings as required
Develop the Data Management Plan for a clinical study.
Enter data queries into the CDMS 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 and provide input when appropriate
Work with study teams to define requirements to create 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 under the general direction of the international IT program manager
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
Location: Rockville, MD
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, e.g., SAS, C#, R, or comparable.
Experience with regard to the application of CDISC standards to clinical research databases.
At least 3 to 5 years of experience with advanced database programming. (Setup and programming skills specifically for the CDMS REDCap would be highly advantageous)
At least 3 to 5 years of experience working as part of an interdisciplinary team on biomedical research projects, specifically with clinical trials.
SAS and/or R programming skills would be highly advantageous
Must have great customer service and interfacing with customer’s experience required.
Excellent oral and written communication skills.
Proficiency in Word, Excel, and PowerPoint.
Must know and understand the application of HIPAA regulations within clinical research.
Must know and understand the application of Good Clinical Practice.
Requires 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. Prefer US Citizens or Permanent Residents.
NETE is a multi-award winning company as well as offers a collaborative working environment where growth is encouraged and nurtured. In addition, we offer competitive salaries that may include performance bonuses; and a comprehensive benefits package.
Net Esolutions Corporation (NETE) uses E-Verify to validate all new hires' ability to legally work in the United States. Net Esolutions Corporation (NETE) is also an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, or veteran or disability status. AmeriCorps, Peace Corps, and other national service alumni are encouraged to apply.