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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