Clinical Data Manager

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          "text": "<p>Trident Consulting is currently seeking a <strong>Clinical Data Manager</strong> for one of our industry leading clients.</p><p><strong>Role: Clinical Data Manager II </strong></p><p><strong>Location: Aliso Viejo, CA - Onsite<br>\nDuration: 6 Months<br>\nShift: 1st Shift<br>\nEmployment Type: Temporary / Contract</strong></p><p><strong>Pay: $26/hr - $29/hr on W2(Inclusive all)</strong></p><p><strong>Position Summary</strong></p><p>Client is seeking an experienced <strong>Clinical Data Manager II</strong> to support clinical study data management activities from study startup through study closeout. This role will be responsible for ensuring the quality, integrity, and compliance of clinical trial data while collaborating closely with cross-functional clinical teams. The ideal candidate will have hands-on experience in clinical data management, EDC systems, data review, and regulatory compliance within pharmaceutical, biotechnology, medical device, or CRO environments.</p><p><strong>Key Responsibilities</strong></p><ul><li>Author, review, and maintain Data Management documentation, including:<ul><li>Data Management Plans (DMPs)</li><li>Project Plans</li><li>CRF Completion Guidelines</li><li>Edit Check Specifications</li><li>Data Review Guidelines</li></ul></li><li>Coordinate and execute User Acceptance Testing (UAT) activities for clinical databases and EDC systems.</li><li>Facilitate Data Management meetings with Clinical Operations, Project Management, Programming, Regulatory Affairs, and Study Teams.</li><li>Manage EDC study deliverables and support database management activities.</li><li>Lead ongoing data cleaning and query management efforts.</li><li>Review clinical data for trends, inconsistencies, quality issues, and outliers.</li><li>Generate, track, and resolve data queries.</li><li>Provide study data status updates, metrics, and reporting to stakeholders.</li><li>Review SAS and SDTM datasets to ensure data quality and regulatory compliance.</li><li>Support external data reconciliation and third-party vendor data review.</li><li>Collaborate with programming teams to create custom reports, listings, and data review outputs.</li><li>Support medical coding and AE/SAE reconciliation activities.</li><li>Maintain audit-ready Data Management documentation.</li><li>Monitor study enrollment and provide enrollment metrics.</li><li>Assist in developing training materials for investigators, clinical sites, and internal teams.</li><li>Contribute to process improvements, SOP development, and best practices within Data Management.</li></ul><p><strong>Required Qualifications</strong></p><ul><li>2–5 years of Clinical Data Management experience.</li><li>Experience within Pharmaceutical, Biotechnology, Medical Device, or CRO environments.</li><li>Strong knowledge of FDA, ICH-GCP, and clinical data management regulations and guidelines.</li><li>Hands-on experience with Electronic Data Capture (EDC) systems such as:<ul><li>Medidata RAVE</li><li>Oracle Inform</li><li>iMedNet</li><li>Similar EDC platforms</li></ul></li><li>Experience with clinical database design concepts and data review tools.</li><li>Knowledge of CDISC standards including CDASH and SDTM.</li><li>Experience writing and maintaining Data Management documentation.</li><li>Experience with data review, query management, and reconciliation processes.</li><li>Strong project coordination, organizational, and analytical skills.</li><li>Excellent verbal and written communication skills.</li><li>Experience with SAS, SQL, Excel, or related data analysis tools is a plus.</li><li>Bachelor's degree or higher in Biological Sciences, Nursing, Healthcare, or a related discipline preferred.</li></ul><p><strong>Preferred Qualifications</strong></p><ul><li>Ophthalmology clinical research experience.</li><li>Medical device clinical trial experience.</li><li>Experience supporting regulatory submissions and inspection readiness activities.</li></ul><p><strong>Required Skills</strong></p><ul><li>Clinical Data Management</li><li>Electronic Data Capture (EDC) Systems</li><li>Medidata RAVE / Oracle Inform / iMedNet</li><li>UAT Testing</li><li>Data Cleaning &amp; Validation</li><li>Query Management</li><li>CDISC Standards (CDASH, SDTM)</li><li>SAS and SQL</li><li>Clinical Trial Documentation</li><li>Regulatory Compliance (FDA, ICH-GCP)</li><li>Medical Coding &amp; Reconciliation</li><li>Cross-Functional Collaboration</li><li>Project Coordination &amp; Reporting</li></ul><p><strong>Nice-to-Have Skills</strong></p><ul><li>Ophthalmology Studies</li><li>Medical Device Clinical Trials</li><li>External Data Reconciliation</li><li>Safety Data Review</li><li>Clinical Reporting &amp; Metrics Generation</li></ul>",
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