Job Description

• Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget.
• Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated.
• Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team.
• Oversee data review, reconciliation, and cleaning activities for all assigned studies.
• Ensure high data quality by adhering to corporate, industry, and regulatory standards.
• Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection.
• Cultivate effective working relationships with colleagues, junior staff, vendors, and management, solving problems and escalating issues with proposed solutions as needed.
• Educate clinical team members on data management processes, workflow, and data standards.
• Review and provide input on protocols, SOPs, and work instructions for the data management department.
• Perform ongoing review of study documentation in the trial master file to ensure audit readiness.
• Perform other related duties as required and assigned.

• Bachelor's degree or equivalent combination of education, 7+ years of relevant experience in clinical data management within biotech or pharmaceutical/drug development.
• Preferred experience in vendor management and global operations.
• Ability to work effectively in a smaller company environment, particularly in early development roles.
• Strong planning and project management skills, including risk assessment and contingency planning.
• Effective communication and interpersonal skills.
• Ability to work as a team player in a complex, changing environment.
• Self-motivated, independent, and results oriented.
• Excellent organizational and problem-solving skills with attention to detail.

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