Job Description
Responsibilities for this Position
Location: USA MD Home Office (MDHOME)
Full Part/Time: Part time
Job Req: RQ201492
Type of Requisition: Regular
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 Research, MedDRA, WHODrug
Certifications: None
Experience: 6 + years of related experience
US Citizenship Required: Yes
Job Description: GDIT's Military Health team is hiring a Clinical Safety Coder - MedDRA/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. The Clinical Safety Coder - MedDRA/WHOdrug encodes terms reported as adverse events and medical history as well as prior and concomitant medications using industry accepted dictionaries such as MedDRA and WHOdrug. This is a hybrid position, and will report onsite 1 day a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - 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
- Perform coding in accordance with departmental coding conventions and SOPs.
- Collaborate with project team during study startup to ensure proper coding setup.
- Create and maintain standard test data for validation of coding tool and interface to database.
- Perform user acceptance testing of coding system and database for each study going into production.
- Configure coding tool for each study with appropriate dictionaries and versions per DMP.
- Create project-specific eCRF guidelines for capturing safety data and train sites for each trial.
- Provide completed medical coding reports using Medical Dictionary for Regulated Activities and World Health Organization Drug Dictionary per the FDA and industry guidance, completed CRFs and related queries and audit trail reports, which document resolved queries during study conduct and closure and all database changes, the reasons data were changed/updated, timestamps (date and time), and who made the changes during study conduct and closure activities according to project timelines.
- Generate and resolve data queries for clarification of data to be coded.
- Create project-specific coding conventions as necessary in collaboration with Principal Investigator.
- Oversee/review external coding (from vendors and other commands) and provide feedback.
- Create and QC coding reports, coordinate PI coding review, and ensure all approvals are obtained.
- Create SAE listings, coordinate SAE reconciliation with Safety group, ensure approvals are obtained.
- Collaborate to implement dictionary version/format upgrades, such as WHODrug Global C3 format.
- May prepare change requests to the MedDRA MSSO.
- Develop and present two day hands-on internal coding training.
- Develop/maintain standard ORA coding guidelines, coding process instructions, eCRF safety data guidelines, protocol-specific coding conventions template, and coding report templates
- Contribute to SOPs and coding working practices, create/maintain instructions for backup coder.
- Communicate with FDA regarding regulations/guidelines related to clinical coding.
- Contribute to ongoing improvement and streamlining of coding processes.
- Troubleshoot and consult with project team to resolve all system and coding issues.
WHAT YOU'LL NEED TO SUCCEED: - Bachelor's degree
- Certified MedDRA Coder
- 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.
- Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
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 #militaryhealth #GDITLabScienceJobs #GDITFedHealthJobs The likely salary range for this position is $72,509 - $40,250. 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: 20
Travel Required: None
Telecommuting Options: Hybrid
Work Location: USA MD Home Office (MDHOME)
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.
Join our Talent Community to stay up to date on our career opportunities and events at
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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
PI274139753
GDIT's Military Health team is hiring a Clinical Safety Coder - MedDRA/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. The Clinical Safety Coder - MedDRA/WHOdrug encodes terms reported as adverse events and medical history as well as prior and concomitant medications using industry accepted dictionaries such as MedDRA and WHOdrug. This is a hybrid position, and will report onsite 1 day a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - 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
- Perform coding in accordance with departmental coding conventions and SOPs.
- Collaborate with project team during study startup to ensure proper coding setup.
- Create and maintain standard test data for validation of coding tool and interface to database.
- Perform user acceptance testing of coding system and database for each study going into production.
- Configure coding tool for each study with appropriate dictionaries and versions per DMP.
- Create project-specific eCRF guidelines for capturing safety data and train sites for each trial.
- Provide completed medical coding reports using Medical Dictionary for Regulated Activities and World Health Organization Drug Dictionary per the FDA and industry guidance, completed CRFs and related queries and audit trail reports, which document resolved queries during study conduct and closure and all database changes, the reasons data were changed/updated, timestamps (date and time), and who made the changes during study conduct and closure activities according to project timelines.
- Generate and resolve data queries for clarification of data to be coded.
- Create project-specific coding conventions as necessary in collaboration with Principal Investigator.
- Oversee/review external coding (from vendors and other commands) and provide feedback.
- Create and QC coding reports, coordinate PI coding review, and ensure all approvals are obtained.
- Create SAE listings, coordinate SAE reconciliation with Safety group, ensure approvals are obtained.
- Collaborate to implement dictionary version/format upgrades, such as WHODrug Global C3 format.
- May prepare change requests to the MedDRA MSSO.
- Develop and present two day hands-on internal coding training.
- Develop/maintain standard ORA coding guidelines, coding process instructions, eCRF safety data guidelines, protocol-specific coding conventions template, and coding report templates
- Contribute to SOPs and coding working practices, create/maintain instructions for backup coder.
- Communicate with FDA regarding regulations/guidelines related to clinical coding.
- Contribute to ongoing improvement and streamlining of coding processes.
- Troubleshoot and consult with project team to resolve all system and coding issues.
WHAT YOU'LL NEED TO SUCCEED: - Bachelor's degree
- Certified MedDRA Coder
- 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.
- Must be a US Citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
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
Job Tags
Holiday work, Full time, Temporary work, Part time, Immediate start, Remote job, Worldwide, Home office, Flexible hours, 1 day per week,