Description
JOB SUMMARY
The Lead Clinical Data Manager leads the execution and delivery of data management projects to ensure that resources and deliverables are achieved to the highest quality.
RESPONSIBILITIES
· Oversee cross-functional study teams to undertake global studies of clinical trials.
· Work on Database/CRF design as per protocol requirements for clinical studies,
· Support/perform development/quality reviews of key study documents & validation/User Acceptance Testing (UAT) of clinical data management systems/database associated edit checks
· Perform all data management activities, processing & reconciliation/query generation/resolution/validation/medical coding/quality review tasks/database lock/archiving of study
· Resolve issues related to quality/project delivery/compliance/client relationships.
· Maintain electronic trial master files and ensure project files/documents are in an audit-ready state.
· Serve as a mentor for project team training in data Management systems/processes.
Salary
$125,000 to $155,000/year
Requirements
· MS in Biomedical Engineering/Biotechnology or a closely related life science discipline.
· Minimum 2 years of experience in clinical data management.
· Must be experienced in multiple clinical data management systems/EDC, such as Medrio & DSG eCaselink.
· Sound knowledge of therapeutic areas (e.g., Oncology/Immunology/Infectious diseases/Neurological disease).
· Familiar with ICH GCP guidelines & FDA regulatory requirements.
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