Job Description

• Ensures The Accuracy and Consistency of Clinical Databases.
• Reviewing data and identifying errors/inconsistencies.
• Collaborating with appropriate project teams to prevent and resolve data issues.
• Tracking outstanding issues and following up until resolution.
• Preparing and validating study metrics and ad hoc data listings as necessary.
• Develop and maintain appropriate clinical data management documentation including but not limited to Data Management Plan, Data Quality Review Plan, User Acceptance Testing Plan, CRF Completion Guidelines (CCGs), document change control logs, training requirements and records.
• Facilitate Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality, and completeness. Meet milestone events such as database go-live, interim database freeze, database locks, and DSMB reviews.
• Complete projects and tasks in a manner consistent with corporate goals and objectives.
• Support Clinical Operations to evaluate EDC vendors, and system functionality requirements for the study, as needed.
• Represent Data Management on cross-functional project.
• Support the system vendor selection process to assess system capabilities with study team needs.
• Program periodic study reports and training materials upon request.
• Maintenance of the EDC database throughout the study including mid-study changes.

• BA degree preferably in the computer sciences, or related discipline.
• Years of relevant clinical data management experience using multiple EDC platforms may substitute for a degree in some cases.
• 3+ years in a CDM department in a device, biopharmaceutical or CRO setting.
• Strong knowledge and experience of EDC systems (e.g., iMednet, Medrio, and other EDC platforms), IRT, CTMS, eTMF, and ePRO preferred.
• Demonstrated knowledge of Microsoft Office Suite.
• Well versed in industry trends and emerging technologies supporting data collection.
• Knowledge of FDA submission requirements, [e.g., Investigational Device Exemption (IDE)].
• Working knowledge of regulatory requirements such as ISO 14155, FDA regulations (CFR 11, 50, 54, 56, 812) and ICH Good Clinical Practice (required).

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