Data Manager II - IDCRP (Remote)

Overview

Join the HJF Team!

HJF is seeking a Clinical Data Manager II who will be responsible for managing and coordinating all aspects of the data management process in support of research activities within the Infectious Disease Clinical Research Program. The incumbent will be a member of the Data Coordination Center, which is responsible for providing data processing and analytical support to the Infectious Disease Clinical Research Program. Responsibilities include study data project planning and management, development of CRFs and other data collection instruments, coordination of other DCC study team member activities, development and maintenance of the data management plan, data entry guidelines and coding manuals, generation and distribution of reports and data forms, data validation and data clarification resolution, and site training as needed for specific studies.

This position will be in support of the Infectious Disease Clinical Research Program (IDCRP). The IDCRP was founded in 2005 under an interagency agreement between the Uniformed Services University of the Health Sciences (USU) and the National Institute of Allergy and Infectious Diseases (NIAID) and through a cooperative agreement with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF). IDCRP’s work is executed through a unique, adaptive, and collaborative international clinical research network. This network directly affects force readiness by advancing clinical practice and informing health policy for military personnel.

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.

Responsibilities

• Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities.
• Lead a multi-functional team of data-related resources including data system programmers, and SAS and Oracle programmers.
• Work with project management staff to define timelines of assigned studies to ensure study milestones are met.
• Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.
• Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.
• Develop and maintain study-specific Data Management Plans.
• Develop and maintain study-specific Data Quality Management and Validation Plans.
• Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.
• Perform EDC data collection instrument User Acceptance Testing.
• Record the receipt, track, and distribute research documents through the data management and verification process in a timely and accurate fashion.
• Maintain files for storage of research documents.
• Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.
• Manage query submission, tracking and resolution for single complex studies or group of studies
• Ensure research data are maintained at the highest level of quality, working with all appropriate staff to discover and address quality issues.
• Review study databases for incomplete/missing data and other data issues.
• Oversee the activities of other DCC staff assigned to manage studies.
• Reconcile discrepancies and obtains guidance when values are questionable or illegible.
• Interact with clinical personnel to resolve omissions, discrepancies, or any other data management issues.
• Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.
• Generate, distribute, track, enter resolution, annotate, and file data entry reconciliation reports and data clarifications within the study folders.
• Verify computer-generated output against original data.
• Check work for accuracy on a daily basis according to established procedures.
• Report any system/data errors and/or problems to their supervisor.
• Assist clinical users in database interaction as necessary, performing queries upon supervisor’s direction.
• Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.
• Adhere to department Standard Operating Procedures for all data management responsibilities.
• Perform other duties as required.
  
  

Qualifications

Education and Experience

• Bachelor's Degree
• Minimum of 3-5 years Data Management experience in a clinical research environment, with at least 2 years’ experience as a Data Manager.
  
  

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.).
• Ability to manage multiple studies of medium complexity or size concurrently.
• In-depth knowledge of Good Data Management Practices, as defined by the Society for Clinical Data Management.
• In-depth knowledge of Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies performed within the IDCRP.
• Experience using at least one clinical data management system (e.g., REDCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical).
• Ability to work independently, as part of a team setting, and meet deadlines.
• Excellent verbal and written communication skills, good organizational, interpersonal skills, and demonstrated ability to take the lead on projects.
• Ability to learn new systems when necessary for job completion (ex: DB Visualizer, and Basic SAS).
• Customer-oriented outlook.
• Must be detail oriented; possess problem solving skills, and the ability to handle multiple tasks and set priorities appropriately.
• Adaptable to changes in work duties, responsibilities, and requirements.
• Ability to obtain and maintain a T1/Public Trust background check.
  
  

Work Environment

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

Compensation

• The likely salary range for this position is $55,000-$75,000 annually based on a 40-hour work week. This is not, however, a guarantee of compensation or salary. Final salary will be determined based on market analysis, experience, and education.
  
  

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

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.