The oversees the studies to drive innovative database building, data collection, tracking and review solutions from complex, diverse sources to ensure timely delivery of high-quality data in a regulated and changing global clinical trial environment.
The role involves interfacing with statisticians, clinical affairs representatives, and external partners and vendors to design, configure, and test the clinical database systems. The CDM II will also be involved in troubleshooting any issues on behalf of the end users and maintaining data standards.
The position will report to the Director of Data Management within Medical, Biostatistical and Design Quality (MBDQ).
Collaborates with Clinical Affairs team to understand changes and help develop data and technology strategies to support those business strategies
Participates in the review of Clinical research documents (e.g., Protocols, Case Report Forms, and Statistical Analysis Plans)
Develops and maintains the Data Management Plan (DMP) throughout the lifecycle of study project and ensures that the DMP is followed according to study design and requirements
Develops electronic Case Report Form (CRF)
Develops database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
Works with Database Engineer to create the EDC database specification
Conducts the User Acceptance Testing (UAT) of the database prior to moving study to production
Creates the eCRF Completion Guidelines
Responsible for database lock/unlock/relock activities
Creates data listings for data management review purposes, summary table validation and data specifications for data management audit(s) as applicable
Coordinates the archiving of study databases and related documents
Performs close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases
Participates in conference calls and/or meetings with study team
Adheres to data management SOPs and work instructions
Assist in defining and/or creating data listings for data management review purposes, summary table validation, and data specifications for data management audit
Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management database(s)
Represents DM function at project team meetings. Contributes to departmental process improvement initiatives
At least eight (8) years data management and/or related work experience in a medical device or pharmaceutical industry/company
Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology
Experience working within a Clinical EDC system (e.g., Oracle Clinical, Medrio, Medidata Rave)
Exposure to clinical data coding classification systems, e.g., MedDRA, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository
Programming knowledge of SAS, R, &/or SQL is desired
Strong interpersonal, organizational, and communication skills
Excellent attention to detail and problem-solving skills
Ability to work effectively work in a team setting
Job ID: 188430
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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