2 days ago

Job Description

  • 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.)
  • Manages multiple, highly complex and/or large studies concurrently.
  • Applies good data management practices as defined by the Society for Clinical Data Management.
  • Applies Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies.
  • Manages Data Managers and mentors others in data management best practices.
  • May include budgetary responsibility to include plan/forecast effort and travel for various projects.
  • May provide project management for DCAC service delivery across multiple studies, to include:
  • Oversee and coordinate across DCAC Data Management, Programming, and Data Analysis teams; in particular, the specification, programming, testing, and documentation of the following: (a) data collection forms, plans and processes; (b) clinical data management databases, (c) database edit checks, (d) programs that generate statistical tables, listings, and figures, and (e) analysis databases (derived datasets) and transfers of data to internal and external clients.
  • Liaise with Investigators, Clinical Research Coordinators, Clinical Project Managers, and other protocol team members to develop and document DCAC requirements for support of data management and analytic needs of research protocols.
  • 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.

Supervisory Responsibilities

  • Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

Join the HJF Team!

HJF is seeking a Senior Clinical Data Manager to manage and coordinate all aspects of the data management process in support of clinical research activities within the Data Coordinating and Analysis Center (DCAC). This involves managing staff and performing all data management activities for clinical trials and observational research studies.

This position will be in support of the Data Coordinating and Analysis Center (DCAC). DCAC is an in-house centralized resource for clinical data management, biostatistical analysis, reporting, and training in support of clinical trials and other scientific research. The Senior Clinical Data Manager will provide data management support for new and ongoing HIV and other emerging infectious disease studies conducted by the U.S. Military HIV Research Program, involving clinical observational research, laboratory research, and clinical trials. This position may also provide data management support to other programs such as the Viral Diseases Program or other programs affiliated with the Walter Reed Army Institute of Research.

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.

Numbers & Facts

LocationBethesda, MD

Skills

  • Analysis Skillsunmatched
  • Best Practicesunmatched
  • Budgetingunmatched
  • Case Report Form (CRF)unmatched
  • Clinical Dataunmatched
  • Clinical Data Managementunmatched
  • Clinical Researchunmatched
  • Clinical Supportunmatched
  • Clinical Trialunmatched
  • Clinical Trial Managementunmatched
  • Data Analysisunmatched
  • Data Collectionunmatched
  • Data Entryunmatched
  • Data Managementunmatched
  • Data Setsunmatched
  • Delivery Managementunmatched
  • Disciplinary Actionunmatched
  • Diseaseunmatched
  • Disease Investigationunmatched
  • Documentationunmatched
  • FDA (Food and Drug Administration)unmatched
  • Forecastingunmatched
  • GCP (Good Clinical Practices)unmatched
  • HIV/AIDS (Acquired Immune Deficiency Syndrome)unmatched
  • ICH Regulationsunmatched
  • Infectious Diseasesunmatched
  • Medical Researchunmatched
  • Medicineunmatched
  • Mentoringunmatched
  • Militaryunmatched
  • Nonprofitunmatched
  • People Managementunmatched
  • Performance Analysisunmatched
  • Performance Reviewsunmatched
  • Project/Program Coordinationunmatched
  • Project/Program Managementunmatched
  • Protocol Analysisunmatched
  • Quality Assuranceunmatched
  • Regulatory Requirementsunmatched
  • Research Laboratoryunmatched
  • Research Protocolsunmatched
  • Scientific Researchunmatched
  • Service Deliveryunmatched
  • Statistical Programming Languagesunmatched
  • Testingunmatched
  • United States Militaryunmatched

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