Posted today
Secret
$115,000 - $130,000
Unspecified
IT - Database
Frederick, MD (On-Site/Office)
Zachary Piper Solutions is looking for a Clinical Database Developer to join a government-supported clinical research program located in Frederick, MD.
Responsibilities of the Clinical Database Developer include:
· Designing, developing, testing, validating, and maintaining clinical trial databases using InForm GTM, Central Designer, Oracle, and other EDC tools
· Creating and updating eCRFs, database specifications, DMPs, DVPs, testing/validation plans, and user documentation
· Conducting development testing, UAT, database releases, and post-production modifications
· Providing technical support for protocol-specific databases, including issue logging, tracking, and resolution
· Supporting data management activities such as query management, reporting, data exports, system integrations (e.g., IRT, eCOA), and documentation for study start-up through study close
· Collaborating with internal teams and end users, and assisting with database training and troubleshooting
· Ensuring compliance with applicable regulations, guidelines, and study data standards (e.g., 21 CFR Part 11, GCP, ICH, CDASH, SDTM)
Qualifications for the Clinical Database Developer include:
· Bachelor's degree in Computer Science or related field, or equivalent experience
· 5+ years of clinical database development experience, including data management oversight
· Hands-on experience with InForm GTM, Central Designer, Oracle, and EDC systems
· Experience reviewing SOPs, technical documents, and validation materials
· Ability to obtain a Secret clearance
· Strong communication skills and experience supporting end users
Compensation for the Clinical Database Developer includes:
· Rate Range: $115,000-$130,000 based on experience
· Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
This job is open for applications on January 26th. Applications will be accepted for at least 30 days from the posting date.
Keywords: Clinical Database Development, InForm GTM, Oracle InForm, Central Designer, Oracle Clinical, Oracle RDC, Electronic Data Capture (EDC), eCRF Design, CRF Programming, Database Build, Database Validation, Database Testing, User Acceptance Testing (UAT), Edit Checks, Data Validation, Data Management Plan (DMP), Data Validation Plan (DVP), Testing & Validation Documentation, Test Scripts, Annotated CRF, SAS Datasets, Data Exports, Data Listings, CDASH, SDTM, SDTMIG-MD, Controlled Terminology, Therapeutic Area Standards, 21 CFR Part 11 Compliance, GCP Compliance, ICH Guidelines, GCDMP, ISO 14155, Data Integration, IRT, RTSM, eCOA, Data Transfer Specifications, Data Transfer Agreements, Clinical Data Workflows, Query Management, Audit Trail Review, CRDMS, Clinical Research Data Management System, Technical Troubleshooting, Issue Tracking, Database Release Management, Database Lock/Unlock, Edit Check Programming, Visit Structure Configuration, Form Workflow Logic, Dynamic Form Generation, Data Dictionary Creation, Metadata Management, Clinical Database Specifications, Clinical Study Database Design, Clinical Research Systems, Clinical Trial Data Handling, Clinical System Interoperability, Biostatistics Data Output Support
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Responsibilities of the Clinical Database Developer include:
· Designing, developing, testing, validating, and maintaining clinical trial databases using InForm GTM, Central Designer, Oracle, and other EDC tools
· Creating and updating eCRFs, database specifications, DMPs, DVPs, testing/validation plans, and user documentation
· Conducting development testing, UAT, database releases, and post-production modifications
· Providing technical support for protocol-specific databases, including issue logging, tracking, and resolution
· Supporting data management activities such as query management, reporting, data exports, system integrations (e.g., IRT, eCOA), and documentation for study start-up through study close
· Collaborating with internal teams and end users, and assisting with database training and troubleshooting
· Ensuring compliance with applicable regulations, guidelines, and study data standards (e.g., 21 CFR Part 11, GCP, ICH, CDASH, SDTM)
Qualifications for the Clinical Database Developer include:
· Bachelor's degree in Computer Science or related field, or equivalent experience
· 5+ years of clinical database development experience, including data management oversight
· Hands-on experience with InForm GTM, Central Designer, Oracle, and EDC systems
· Experience reviewing SOPs, technical documents, and validation materials
· Ability to obtain a Secret clearance
· Strong communication skills and experience supporting end users
Compensation for the Clinical Database Developer includes:
· Rate Range: $115,000-$130,000 based on experience
· Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
This job is open for applications on January 26th. Applications will be accepted for at least 30 days from the posting date.
Keywords: Clinical Database Development, InForm GTM, Oracle InForm, Central Designer, Oracle Clinical, Oracle RDC, Electronic Data Capture (EDC), eCRF Design, CRF Programming, Database Build, Database Validation, Database Testing, User Acceptance Testing (UAT), Edit Checks, Data Validation, Data Management Plan (DMP), Data Validation Plan (DVP), Testing & Validation Documentation, Test Scripts, Annotated CRF, SAS Datasets, Data Exports, Data Listings, CDASH, SDTM, SDTMIG-MD, Controlled Terminology, Therapeutic Area Standards, 21 CFR Part 11 Compliance, GCP Compliance, ICH Guidelines, GCDMP, ISO 14155, Data Integration, IRT, RTSM, eCOA, Data Transfer Specifications, Data Transfer Agreements, Clinical Data Workflows, Query Management, Audit Trail Review, CRDMS, Clinical Research Data Management System, Technical Troubleshooting, Issue Tracking, Database Release Management, Database Lock/Unlock, Edit Check Programming, Visit Structure Configuration, Form Workflow Logic, Dynamic Form Generation, Data Dictionary Creation, Metadata Management, Clinical Database Specifications, Clinical Study Database Design, Clinical Research Systems, Clinical Trial Data Handling, Clinical System Interoperability, Biostatistics Data Output Support
#LI-MU1
#LI-ONSITE
group id: 10430981
