Data Manager III, Hybrid

Overview

Join the HJF Team!

HJF is seeking a Data Manager III to manage and coordinate all aspects of the data management process in support of research activities within the Program.

Responsibilities include study planning, development of data collection instruments, coordination of other 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 Military Traumatic Brain Injury Initiative (MTBI2).

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

• 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; and related regulatory requirements and terminology for clinical studies.
• Leads projects.
• May include budgetary responsibility to include plan / forecast, prepare and monitor.
• 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.

Qualifications

Education and Experience

• Bachelor's Degree, Master's preferred
• Minimum of 6-8 years experience required

Required Knowledge, Skills and Abilities

• Proficiency in the understanding, development, and execution in all aspects of clinical trial Data Management (e.g., case report form design, data entry instructions, data management and quality assurance plans, resource planning, data status tracking, etc.).
• Ability to manage multiple, highly complex and / or large studies concurrently.
• Expert knowledge of good data management practices as defined by the Society for Clinical Data Management.
• Expert knowledge of Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies.
• Experience managing all data-related aspects of studies with FDA-regulated substances, particularly for INDs.
• Advanced knowledge of at least one clinical data management system (e.g., REDCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical).
• Ability to obtain and maintain a T1 / Public Trust background check.

Supervisory Responsibilities

Assigned Lead : May recommend the following : employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.

Physical Capabilities

Lifting : Requires lifting materials up to 10 lbs.

Work Environment

• This position will take place primarily in an office setting.
• This is a hybrid work arrangement.

Note : This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.

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.

Ensure all your application information is up to date and in order before applying for this opportunity.

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Remote working / work at home options are available for this role.