Manager, Clinical Data Management Study Lead

What you'll do

• Oversee lead Data Managers and manage all data management activities from study start-up through archiving.
• Serve as the primary point of contact for clinical study teams and external partners like CROs.
• Provide technical expertise on eCRF design, database construction, and data quality reporting to project members.
• Manage data transfers with third-party sources, including SAE/AE reconciliation and MedDRA/WHO-DD coding.
• Oversee the implementation of procedures for data quality review and acceptance before database locks.
• Identify and resolve gaps in CRO performance, documentation, and process execution.
• Develop and maintain SOPs, Working Practices, and Data Management Plans to meet company standards.
• Perform inspection readiness tasks and ensure all deliverables meet established timelines 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.
• Experience overseeing all stages of trial data management from start-up through archiving.
• Expertise in eCRF and database design, data quality review, and reporting of status to project teams and CROs.
• Ability to manage data transfers with external vendors, including SAE/AE reconciliation and MedDRA/WHO-DD coding.
• Experience performing quality review and inspection readiness tasks to meet quarterly compliance requirements.
• Ability to identify risks, propose mitigations, and proactively escalate operational or vendor issues.