Senior Clinical Data Manager

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Contract Senior Clinical Data Manager

Key Responsibilities

• Serve as the data management lead on assigned studies, representing DM on cross-functional study teams and providing input on timelines and deliverables
• Author and review study-level data management documents, including Data Management Plans, CRF annotations, data transfer specifications, coding conventions, and reconciliation plans
• Oversee database setup, migrations, and updates, including coordination and execution of UAT
• Lead internal data review planning and coordinate cross-functional listing review activities
• Perform scheduled and ad hoc data listing review; generate and resolve queries in EDC
• Execute external data reconciliation and SAE reconciliation in accordance with SOPs
• Manage and monitor CRO and vendor data management activities, maintaining effective working relationships with counterparts
• Distribute and review data management metrics, listings, and reports
• Support statisticians and statistical programmers in the production of clinical trial reports and other study deliverables
• Contribute to departmental SOP, template, and process development
• Provide training and guidance to junior data managers and clinical data associates

Qualifications

• Bachelor’s degree in life sciences, health sciences, mathematics, computer science, or a related field
• Minimum of 5 years of data management experience in the pharmaceutical or biotechnology industry
• Oncology experience strongly preferred
• Working knowledge of ICH, FDA, and GCP regulations and guidelines
• Experience with EDC systems and industry thesauri (MedDRA, WHO Drug)
• Familiarity with CDISC, SDTM, and CDASH standards
• CRO or service provider management experience a plus

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