Data Manager MedRA Coder (WHODrug)

Type of Requisition:

Pipeline

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

NACI (T1)

Job Family:

Medical Affairs

Job Qualifications:

Skills:

Clinical Data Management, Electronic Data Capture (EDC), MedDRA Coding, WHODrug

Certifications:

None

Experience:

5 + years of related experience

US Citizenship Required:

Yes

Job Description:

GDIT's Military Health team is hiring Data Manager MedRA Coder (WHODrug) to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.

The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.

This is a hybrid position, reporting onsite 1 -2 days a week to Ft. Detrick in Frederick, Maryland. Must reside within commuting distance.

HOW YOU WILL MAKE AN IMPACT:

Responsible as an oversight or a performer data manager across multiple projects for the following, but are not limited to, data management activities and deliverables in various phases of the clinical trial lifecycle (e.g., pre-study start, study start up, study conduct, and study closure). This position will provide data management support according to the applicable FDA regulations, guidance, and industry standards which includes performing clinical data management activities or providing clinical data management oversight, support responsibilities.

Clinical Data Management Tasks:

• Develop a Data Management Plan which is a comprehensive document developed to describe all data management activities and their processes and implementation during pre-study conduct, study conduct, and study closure and that reflect Good Data Management Practices based on good Clinical Data Management Practices, Good Clinical Practices, and ICH guidelines.

• Develop CRFs which are a series of questionnaire forms used as a data collection instrument for accurately and completely capturing the data required by the clinical protocol, that meet the FDA submission requirements and conform to Clinical Data Interchange Standards Consortium (CDISC)/ Clinical Data Acquisition Standard Harmonization (CDASH) standards and Study Data Tabulation Model (SDTM) controlled terminology.

• Develop database specifications, which describe all study-specific design, testing, and validation requirements, following CDISC/CDASH standards and SDTM Controlled

• Perform and document database testing and validation (initial production release and post go-live), which consists of a plan describing the User Acceptance Testing and validation processes/procedures of the study-specific database, testing scripts/documents, and validation documentation and is in place prior to the initial database production release and all subsequent database modifications during the study conduct

• Develop technical support plans that include end user support and the development, modification, maintenance, testing, and validation of the protocol-specific Electronic Data Capture (EDC) database throughout the life of the trial

• Develop database training support plans, which describe the required trainings that shall be provided to end users, and the associated training materials, which may include but are not limited to agendas, course syllabi, attendance sign-in logs, etc.

• Create data listings and reports (e.g., metrics) that pertain to data management activities during study conduct

• Provide documentation of how study data will be cross-checked and the outcome of the evaluation to ensure quality and accuracy before the study database is locked

• Document data reconciliation through a written report, which indicates that for data where the same data points are collected in more than one source, the applicable CRFs data in the Clinical Data Management System have been reconciled with data in the other system (to include but not limited to, the serious adverse event system and/or the external laboratory databases), prior to database lock (Deliverable 22)

• Provide final raw data