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 in Statistical Analysis Software (SAS) format compliant with CDASH and applicable CDISC standards prior to the transformation to SDTM datasets

• Provide other essential data management documents (e.g., medical coding conventions/guidelines, self-evident corrections), which are documents deemed necessary by the data management team to be important in describing data management activities

• Collect and validate laboratory data in an electronic and analyzable format and in compliance with CDISC

• Collect and manage data according to the applicable FDA regulations, FDA guidance, ICH, CDISC/CDASH Standards, and Good Clinical Data Management Practices.

Medical Coding Tasks:

• Perform medical coding using MedDRA and WHO-Drug dictionaries per the coding guidelines to include MedDRA Guide, MedDRA Points to Consider, MedDRA PTC Companion Document and WHO-Drug Best Practices. Medical coder is responsible for medical coding setup, testing, validation, and maintenance for protocol-specific or version specific, participating in review of study-specific CRFs, CRF instructions, and writing medical coding CRF completion instructions, preparing and conducting end user training pertaining to studies that require medical coding, review of study data patriating to medical coding, reviewing and providing approved coding reports (medical coding and data reconciliation

WHAT YOU’LL NEED TO SUCCEED:

• Bachelor’s degree in computer science, or a related discipline, or the equivalent combination of education, professional training, or work experience.

• 5 years of related data management experience.

• MUST have MedDRA Coding experience (certified preferred)

• 6 years+ WHO-DD coding experience

• 2 years+ related experience in clinical research creating CRF guidelines and project specific coding conventions

• Experience reviewing clinical protocols

• Experience communicating with FDA regarding regulations/guidelines related to clinical coding.

• Experience create/maintain standard test data for testing coding tool and interface with database.

• Experience assigning MedDRA/WHODrug dictionary codes to specified clinical trial data/generate queries per guidelines.

• Excellent written and oral communication skills.

• Location: Onsite in Frederick, MD once a week (must live in commuting distance)

• Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.

• US Citizenship Required

WHAT GDIT CAN OFFER YOU: 

• Challenging work that makes a real impact on the world around you  

• Internal mobility team dedicated to helping you own your career 

• 401K with company match 

• Diverse, highly collaborative teams

• Professional development, education assistance, certification and training opportunities

#GDITHealth

#GDITLabScienceJobs

#MilitaryHealthGDITJobs

The likely salary range for this position is $72,509 - $83,950. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours:

40

Travel Required:

Less than 10%

Telecommuting Options:

Hybrid

Work Location:

USA MD Fort Detrick

Additional Work Locations:

Total Rewards at GDIT:

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans