Senior Clinical Data Manager

Senior Clinical Data Manager Overview

• The Senior Clinical Data Manager will oversee clinical data management processes for complex trials, ensuring compliance with industry standards and regulatory requirements.
• This role involves collaboration with cross-functional teams to enhance operational efficiency and implement best practices in data management.
• The position is remote, offering flexibility and the potential for contract extension or permanent conversion.
• Candidates will lead data management strategies, ensuring quality deliverables and adherence to timelines.
• The role demands staying updated on emerging technologies and trends to drive continuous improvement.
• Ideal for professionals with a strong background in clinical data management and a passion for innovation.

Senior Clinical Data Manager Key Responsibilities & Duties

• Serve as the primary client representative for data management interactions, ensuring adherence to processes and quality standards.
• Provide technical expertise in protocol conversion, database building, CRF design, and data verification.
• Collaborate with technical teams to configure centralized data management platforms for data cleaning and oversight activities.
• Perform quality control on deliverables, including study documents and analytics modules.
• Act as a senior consultant to sponsors, offering guidance on best practices tailored to specific protocols.
• Conduct data trending reviews to identify risks and develop mitigation strategies.
• Delegate tasks effectively, mentor junior staff, and support team development.
• Participate in business development activities, including proposal defenses.

Senior Clinical Data Manager Job Requirements

• Bachelor’s degree in a relevant health science or technical discipline; Master’s preferred.
• Minimum of 7 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• CCDM certification is preferred, along with strong project management and leadership skills.
• Proficiency in Microsoft Office, EDC systems, and clinical data management tools.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
• Experience with cloud SaaS platforms and data reporting tools is advantageous.
• Familiarity with RBQM methodologies and CDISC standards is preferred.
• Excellent communication, analytical, and strategic thinking skills.