Senior Clinical Data Manager

Overview

• Drive clinical data management excellence, ensuring precision and compliance in pharmaceutical research studies within a fully remote environment.
• Collaborate with multidisciplinary teams to design and implement effective data management strategies and solutions.
• Provide expert guidance on electronic data capture systems and data integrity protocols to ensure high-quality outcomes.
• Oversee database design, testing, and modifications to meet dynamic study requirements and regulatory standards.
• Support audits and inspections, addressing findings and ensuring adherence to industry regulations.
• Coordinate with external vendors for seamless integration of non-CRF data management activities.
• Contribute to project planning and tracking, ensuring milestones are achieved efficiently.
• Mentor junior team members, fostering professional growth and enhancing team capabilities.

Key Responsibilities & Duties

• Develop and execute comprehensive data management plans, addressing challenges and ensuring project success.
• Act as the primary contact for data management activities, ensuring seamless communication and collaboration.
• Design and review case report forms and source document templates for clinical trials.
• Perform quality control reviews, ensuring accuracy and compliance in data management outputs.
• Coordinate database modifications to accommodate protocol amendments or study needs effectively.
• Collaborate with programmers for data quality reviews and validation of listings and summary tables.
• Resolve medical coding discrepancies and reconcile serious adverse events efficiently.
• Generate project work orders and amendments, aligning with study objectives and requirements.

Job Requirements

• Bachelor’s degree in health sciences, pharmaceutical sciences, or related fields required.
• Minimum 5 years of experience in clinical trial data management, with leadership capabilities preferred.
• Proficiency in electronic data capture systems and database design processes.
• Strong knowledge of clinical trial regulations, industry guidance, and data management standards.
• Experience in client relationship management and effective project planning.
• Ability to perform quality control audits and resolve data discrepancies effectively.
• Excellent communication and organizational skills to collaborate with cross-functional teams.
• Familiarity with regulatory requirements and compliance standards in clinical research.