Job Title: Data Manager
Locations: Frederick, MD
ATC’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.
Duties and Responsibilities:
- Provide data management support according to the applicable regulations, guidance, and industry standards using a 21 CFR Part 11 compliant clinical data management system. This support will include at minimum the following activities:
- Develop Data Management Plans specifying all data management activities that reflect Good Clinical Data Management Practices based on Good Clinical Data Management Practices (GCDMP), Good Clinical Practices, and ICH guidelines.
- Perform Case Report Development activities
- Document database testing and validation that includes a plan describing the User Acceptance Testing and validation processes/procedures of the study-specific database, testing scripts/documents, and validation documentation.
- 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.
- Perform data quality checks
- Document data reconciliation through a written report.
- Participate in medical coding activities
- Perform database closure activities
- Participate on project meetings
- Participate in special projects as required.
- 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.
- Must be U.S. citizen and be able to obtain a T1.
THIS IS A FEDERAL CONTRACT
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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