Data Manager II, III, or Senior (COVID-19) – Allergy & Immunology

Join the HJF Team!

HJF is seeking a Data Manager II, III or Senior (COVID-19) to support the Allergy & Immunology Department, located at the Defense Health Headquarters in Falls Church, VA. HJF provides scientific, technical, and programmatic support services to Allergy & Immunology Department. U.S. citizenship required.

Manages and coordinates all aspects of the data management process in support of research activities within the Program. Specifically, to analyze the DoD MHS database to identify individuals eligible for the exposure and control groups of the study, generate random samples of controls, and create variables.

NOTE: All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

Responsibilities:

1. Understands, develops, and executes all aspects of clinical trial Data Management (e.g. CRF design, data entry instructions, data management and QA plans, resource planning, data status tracking, etc.).
2. Creates data extracts from larger databases and merging datasets to create analysis-ready files.
3. De-identifies data to strip protected health information and creates HIPAA-compliant data sets, prepares data for transfer.
4. Applies Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies.
5. Ensures compliance with procedures/processes for chart retrieval, chart review, and data abstraction.
6. Follows up on timelines and facilitate chart abstraction in collaboration with Physicians.
7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities:

• Proficiency in the understanding, development, and execution in all aspects of clinical trial Data Management (e.g. CRF design, data entry instructions, data management and QA plans, resource planning, data status tracking, etc.).
• Substantial experience managing all data-related aspects of studies with FDA-regulated substances, particularly for INDs.
• Proficient SAS coding skills.
• Substantial experience in data management in a federated informatics system.
• Experience in cohort identification, i.e., performing identification of a set of patients meeting certain inclusion or exclusion criteria.
• Training in biostatistics or epidemiology preferred.
• Experience in random sample selection and cohort matching is preferred.

Minimum Education: Bachelor’s degree required. Master’s preferred.

Minimum Experience/ Training Requirements:

• Level II: Minimum of 3-5 years of experience required.
• Level III: Minimum of 6-8 years of experience required.
• Senior level: More than 10 years of experience required.

Required Licenses, Certification or Registration: Current DoD Security clearance preferred.

Work Environment: This job takes place in a typical office environment.

Work Arrangement: This position is 100% on site and has no teleworking capability.

Background/Security: U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance and Common Access Card (CAC).

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.