Clinical Database Developer - Central Designer andOracle -- Frederick, MD -- Hybrid -- 67087

One of our clients is looking for a Clinical Database Developer to join their team on a hybrid basis in Frederick, MD.

Must have:

• 5+ years of related clinical database development experience and must have experience providing clinical research data management oversight support
• Must have hands on experience with InForm GTM (very niche, if they have Oracle database experience I don't need InForm experience)
• Must have experience with EDC (Electronic Data Capture)
• Must have experience with Central Designer and Oracle
• Must have experience providing technical support related to protocol-specific data management databases and end users including - initiate, log, track, and maintain progress and history tracking of reported technical problems, corresponding resolutions, and their pertinent information for all projects
• Experience reviewing 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.
• Experience using the MRDC in-house CRDMS a plus
• Excellent written and oral communication skills.

Responsibilities:

• Be responsible as a performer or an oversight Clinical Database Developer 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):
• Participation in the 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.
• Participation in the protocol review (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.
• Participation in the creation and maintenance of Data Management Plans (DMPs) describing the processes and procedures governing the data management activities for producing data management deliverables.
• Participation in the 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.
• Design, development, testing, validation, and maintenance of protocol-specific data management databases meeting and conforming to the approved mock eCRFs (or similar documentation listing the agreed data point collection) or approved database modification requests (post-go live), required study data standards, the protocol-specific requirements and objectives, applicable regulations and guidelines, and the respective systems capabilities and requirements:
• Design, 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.
• Preparation and setup of database instances for development testing, User Acceptance Testing (UAT), training, and production.
• 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, approval, and testing and validation documentation for all protocol-specific data management database modifications implemented after the initial release for production.
• Conduct of development testing and UAT.
• Participation in the creation and maintenance of request and approval documentation for protocol-specific data management database production releases and locking/unlocking.
• 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.
• Participation in the 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.
• Participation in the 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.
• 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)).
• Review of external Data Transfer Plans/Agreements and the supporting transfer specifications, testing and validation documentation (e.g., Central Laboratory, eCOA, Pharmacokinetics (PK)).
• Participation in the 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).
• Participation in the identification and registration of project risks related to data management processes, procedures, activities, and deliverables.

Sravan Kumar Reddy
PRIMUS Global Services
Direct:
Desk: Ext. 226
Email: