Senior Clinical Data Manager

Summary:

The Senior Clinical Data Manager will lead data management activities for assigned clinical studies, ensuring compliance with regulatory standards, study protocols, and company SOPs. This role will act as the primary liaison with project teams and CROs, overseeing data quality from study start-up through data archiving and ensuring databases are validated and ready for analysis.

Responsibilities:

• Serve as the main Data Management contact for assigned studies, collaborating with project teams and external CROs.
• Oversee and coordinate data management activities, including data cleaning, validation checks, and database readiness.
• Ensure data is available and accurate for analysis, meeting regulatory and company standards.
• Prepare and maintain essential project documentation, such as the Data Management Manual (DMM), CRF guidelines, and validation specifications.
• Lead the build, testing, and validation of clinical databases, ensuring smooth transitions to analysis.
• Manage relationships with CROs to ensure data management tasks are performed according to company policies and best practices.

Qualifications:

• Bachelor’s degree in Mathematics, Science, or a related field.
• 7+ years of experience in clinical data management within the biotech, pharmaceutical, or healthcare industries.
• Experience with Phase 3 clinical studies is highly preferred.
• Strong leadership, communication, and organizational skills.
• Proven ability to manage complex data processes and coordinate with cross-functional teams.