Lead Clinical Data Manager

About the position

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.

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.