Senior Clinical Data Manager - DCAC

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Bethesda (MD); On-site; USD 93,000 - 115,000; Full time

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is seeking a Senior Clinical Data Manager to lead data management for HIV and other infectious disease studies within DCAC.

The role involves managing staff, coordinating CRF design, data status, and QA plans across clinical trials and observational research. You will ensure regulatory compliance (GxP, FDA/ICH, CDISC), mentor Data Managers, and collaborate with investigators and project teams to deliver timely,

Qualifications

• Proficiency in clinical trial data management processes across phases
• 60},
• Ability to manage multiple, complex studies concurrently
• Experience with FDA-regulated substances and INDs is preferred
• Expert knowledge of GCP, FDA/ICH, and CDISC standards

Responsibilities

• Understands, develops, and executes all aspects of clinical trial Data Management including CRF design and data status tracking
• Manages multiple complex studies concurrently and mentors data management staff
• Ensures data quality through QA plans and regulatory compliance, including FDA/ICH/CDISC requirements
• Provides project management for DCAC service delivery across studies and liaises with investigators and protocol teams
• Oversees data collection forms, databases, edit checks, and data transfers to clients

Skills

Clinical trial data management

FDA/ICH/CDISC knowledge

Team leadership

Education

Bachelor's Degree in Public Health or related field

Master's degree preferred

Tools

REDCap

Medidata Rave

OpenClinical

Oracle InForm

Oracle Clinical

Job description

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.

• 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.

Education and Experience

• Bachelor's Degree in Public Health or a related field required, Master's degree preferred.
• More than 10 years of experience required.

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, 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, including CDISC.
• 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, OpenClinical, Medidata Rave, Oracle InForm, Oracle Clinical) with knowledge of REDCap preferred.

Physical Capabilities

• Ability to stand or sit at a computer for prolonged periods.

Work Environment

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

Compensation

• The annual salary range for this position is $93,100-$115,000. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

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.