Manager, Clinical Data Manager Study Lead

What you'll do

• Oversee all data management activities for assigned clinical studies from start-up through archiving.
• Serve as the primary point of contact for clinical study teams and external CROs.
• Review and approve study documentation including Data Management Plans, Case Report Forms, and validation specifications.
• Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding processes.
• Perform quality reviews and inspection readiness tasks to ensure compliance with SOPs and WIs.
• Monitor data quality and assess progress on data issue remediation on an ongoing basis.
• Identify risks and propose mitigations for operational or vendor-related issues.
• Develop and manage deliverable timelines to meet business needs and program objectives.

What we're looking for

• Bachelor Degree or equivalent experience in Mathematics, Science, or a related field.
• Clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
• Provide oversight of lead Data Managers on clinical data management studies to ensure deliverables meet standards and timelines.
• Serve as the primary point of contact for clinical study teams and external partners, such as CROs and data vendors.
• Oversee all data management activities from study start-up through archiving, including eCRF design, data quality, and reporting.
• Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding.
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance.
• Review and approve study documentation, including Data Management Plans, Case Report Forms, and validation specifications.