The Henry M. Jackson Foundation for the Advancement of Military Medicine

Data Manager III - Infectious Diseases (Hybrid)

Job Locations US-MD-Bethesda
Program
HJF Global ID
ID
2024-4207
Category
Clinical Research
Position Type
Regular Full-Time
Travel
Up to 10% of the time
Work Arrangements
Hybrid work environment

Overview

Join the HJF Team!

 

HJF is seeking a Data Manager III to support the Data Coordinating and Analysis Center (DCAC) for the Military HIV Research Program (MHRP) and the Emerging Infectious Diseases Branch (EIDB) of the Walter Reed Army Institute of Research (WRAIR), whose Home Office is located at 6720A Rockledge Drive, Bethesda, Maryland. HJF provides scientific, technical, and programmatic support services to MHRP, EIDB, and affiliated programs. 

 

DCAC is an in-house centralized resource for clinical data management, bio-statistical analysis, reporting, and training in support of clinical trials and scientific research. The Data Manager III will provide data management support for new and ongoing HIV and other emerging infectious disease studies conducted by MHRP, EIDB, and affiliated programs, involving clinical observational research, laboratory research, clinical trials, and other research studies.

 

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

 

Learn more about the Military HIV Research Program here!

Responsibilities

  • Interact directly with Principal Investigators, Investigators, Clinical Research Coordinators, and other protocol team members to develop and document DCAC requirements for support of data management as primary study clinical data manager.
  • Design and maintain data entry screens and data management.
  • Drafts and oversees execution of study validation.
  • Develop, plan, and coordinate edit check documentation, quality control documentation, and processes as appropriate for complex studies.
  • Develop, review, store, track, and maintain the following: data management plans; data entry instructions and coding manuals; Standard Operating Procedures (SOPs); case report forms and case report form annotation; form completion instructions; data entry reconciliation reports; documentation manuals; other department and protocol related
  • On-board and mentor other staff in data management procedures as required.
  • Manage query submission, tracking and resolution for single complex studies or a group of studies, including interacting with clinical personnel to reconcile data discrepancies, generating query reports, obtaining resolutions, and tracking and documenting resolutions.
  • Provide assistance and training to clinical users and data entry personnel when new protocols begin, as new screens are added or modified, and on an ad hoc basis as
  • Assist researchers in retrieving information from the databases and other data Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles; status reports; any special purpose ad hoc reports; and, basic univariate statistical analysis reports.
  • Adhere to departmental Standard Operating Procedures (SOPs) for all data management responsibilities, assist in creation of SOPs, and mentor junior Clinical Data Managers on SOPs including quality assurance practices.
  • Identify potential project risks and corresponding solutions to complex data management.
  • Fulfill data management project responsibilities at the level of primary study clinical data manager for single complex studies or group of
  • May perform other duties and responsibilities as assigned or directed by the supervisor.

Supervisory Responsibilities

  • Assigned Lead: May recommend the following: employee hiring and/or disciplinary action; may provide input on employee performance evaluations.

Qualifications

Education and Experience

  • Bachelor's Degree in Computer Science, Information System Management, Data Science, Public Health, Health Informatics, or related field is required. Master's degree is preferred. 
  • Minimum of 6-8 years experience required.

Required Knowledge, Skills and Abilities

  • Proficiency in the understanding and execution of all aspects of clinical trial data.
  • Demonstrated ability to manage multiple, complex and/or large research studies concurrently.
  • Working knowledge of good data management practices as defined by the Society for Clinical Data Management, Good Clinical Practices, FDA, and ICH-related regulatory requirements and terminology for clinical studies.
  • Experience managing data-related aspects of studies with FDA-regulated substances; working knowledge of at least one clinical data management system (e.g. REDCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical).
  • Must have excellent oral and written communication.
  • Preferred skills include: Experience using REDCap; experience with HIV and EID vaccine clinical trials; experience with CDISC standards; experience working with IND's.

Work Environment

  • This position will take place primarily in an office setting.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

 

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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

 

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

 

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

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