Job title: Data Manager
Company: General Dynamics
Job description: Type of Requisition: Pipeline
Clearance Level Must Currently Possess: None
Clearance Level Must Be Able to Obtain: None
Suitability:
Public Trust/Other Required: NACI (T1)
Job Family: Database Analysis/Design
Job Qualifications:
Skills: Data Management, Data Review, Following Protocols
Certifications:
Experience: 5 + years of related experience
US Citizenship Required: Yes
Job Description:
GDIT’s Military Health team is hiring Data Manager 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.
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):
Review of SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems.
Protocol review participation (from the initial drafts to finalization and subsequent amendments)
Creation and maintenance of mock electronic case report forms (eCRFs) for electronic data collection method or CRFs for paper-based data collection method designed conforming to the required study data standards and the protocol-specific requirements and objectives.
Creation and maintenance of Data Management Plans (DMPs) describing the processes and procedures governing the data management activities for producing data management deliverables.
Creation and maintenance of Data Validation Plans (DVPs) outlining quality control checks on CRF data that will be performed manually or programmatically within or externally from the protocol-specific data management databases.
Creation and maintenance of protocol-specific data management database design specifications defining data definitions and structure conforming to the applicable study data standards, visit and form workflow and dynamic generation, warning flag and query generation edit checks, and monitoring/tracking status parameter settings.
Creation and maintenance of protocol-specific data management database testing and validation documentation:
Testing and Validation Plan describing the testing, validation, and documentation processes and procedures in the development testing phase, internal data management team testing phase, and User Acceptance Testing (UAT) phase.
Supporting testing and validation documentation (e.g., test cases/scripts, testing results/findings logs/summary, query listing, data outputs, data extractions, data dictionary, annotated CRF).
Creation and maintenance of request and approval documentation for protocol-specific data management database production releases and locking/unlocking.
Creation and maintenance of request, approval, and testing and validation documentation for all protocol-specific data management database modifications implemented after the initial release for production.
Creation and maintenance of technical support plans describing the scope and level of support for end users on protocol-specific data management database technical issues.
Creation and maintenance of training support plans describing the scope and level of support on protocol-specific data management databases.
Preparation, conduct, and documentation of protocol-specific data management database trainings with end users on, including but are not limited to, data entry, source verification, query management, data management, reporting and data outputs, eCRF approval, and medical coding.
Creation and maintenance of the essential data management documents, including but are not limited to, CRF Completion Instructions, Data Entry Guidelines, Medical Coding Conventions, Self-Evident Corrections, Data Handling Conventions, Data Clarification Forms (DCFs), and Data Management Deliverable Checklist and Tracking.
Data review, cleaning, and discrepancy management.
Data quality assurance and quality control.
Participation in defining specifications and generation of reporting and data exports/outputs (e.g., metrics reports, SAS datasets, customized data listings in Excel format).
Participation in defining system integration requirements and specifications, testing and validation implementation, and integrated data handling and reconciliation plans (e.g., Interactive Response Technologies (IRT), Electronic Clinical Outcome Assessment (eCOA).
Coordination of medical coding review and approval.
Review of external Data Transfer Plans/Agreements and the supporting transfer testing and validation documentation (e.g., Central Laboratory, eCOA, Pharmacokinetics (PK))
External data transfers and reconciliation (e.g., Serious Adverse Event (SAE) reconciliation, lab data reconciliation, eCOA data reconciliation).
Protocol-specific data management database closure, project closure, and study Trial Master File archiving of all data management deliverables (e.g., subject CRFs, final query reports, final audit trial reports, interim and final raw data in Clinical Data Acquisition Standards Harmonization (CDASH), data from external sources/transfers, essential data management documents).
Coordination and preparation for data readiness for data extractions for FDA Annual Reports (ARs), interim analyses, and final Clinical Study Reports (CSRs) and review participation of the reports.
Identification and registration of project risks related to data management processes, procedures, activities, and deliverables.
Project meeting participation.
Special project participation as required.
Provide data management oversight support on data management activities conducted by data management vendors to ensure compliance with the applicable regulations (e.g., 21 CFR Part 11, 21 CFR 312.62(c), 812.140(d), ISO 14155), Good Clinical Data Management Practices (GCDMP), Good Clinical Practices (GCP), and ICH guidelines and to ensure completion, quality, and integrity of data management deliverables meeting the requirements of the project-specific scope of works and agreements, protocols, applicable study data standards (e.g., CDASH, Study Data Tabulation Model (SDTM), Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD), Controlled Terminology, Therapeutic Area), and industry standards.
Provide data management support on data management activities and deliverables as the performer for projects to be conducted by ORA Data Management.
Provide data management support complying with the applicable regulations (e.g., 21 CFR Part 11, 21 CFR 312.62(c), 812.140(d), ISO 14155), GCDMP, GCP, ICH guidelines, study data standards, and industry standards.
Be working in an integrated interdisciplinary team dynamic environment on projects governing under varying regulatory agencies depending on the products (e.g., drugs; vaccines, blood, and biologics; medical devices) and regulatory pathways (e.g., Investigational Device Exemption (IDE), Investigational New Drug (IND), New Drug Application (NDA), Biologic License Applications (BLA), Emergency Use Authorization (EUA)) on clinical research and trials in various phases and design.
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.
Excellent written and oral communication skills.
Location: Onsite in Frederick, MD once a week (must live in commuting distance)
Security Clearance Level: Must be a US citizen with the ability to obtain a favorable NACI T1 security investigation.
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
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#GDITLabScienceJobs
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Scheduled Weekly Hours: 40
Travel Required: Less than 10%
Telecommuting Options: Onsite
Work Location: USA MD Fort Detrick
Additional Work Locations:
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 30 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.
We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation’s most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
Expected salary:
Location: Fort Detrick, MD
Job date: Sun, 29 Oct 2023 05:09:50 GMT
