Clinical Data Manager

Responsibilities :

• Act as the primary Data Management SME, providing expert guidance on data management standards, processes, and best practices.
• Proactively identify risks and contribute to building systems and processes to ensure high data quality and integrity across the organization.
• Oversee and manage external CROs to ensure adherence to project specifications, timelines, and quality expectations.
• Develop, implement, and refine data management strategies, ensuring efficient data processing, quality checks, and reporting.
• Expertly navigate EDC for data capture, validation, and analysis to uphold data accuracy and efficiency.
• Engage with cross-functional teams under Clinical Affairs and Regulatory Affairs, and IT, to ensure integrated and streamlined data management.
• Lead and contribute to the development, review, and editing of critical data management documents, including but not limited to Data Management Plans (DMPs), Data Transfer Agreements (DTAs), Case Report Forms (CRFs) and other documents.
• Organize, maintain, optimize, and audit the internal data repositories and data transfers of the organization to ensure data accessibility, integrity, and compliance.
• Provide comprehensive training and support to internal teams on data management systems, processes, and best practices.
• Proactively identify, troubleshoot, and resolve data-related issues, implementing corrective and preventive measures as necessary.
• Proficiency in both strategic thinking and operational execution is required, including the capability to identify emerging trends and pinpoint the root causes of data discrepancies to proactively address them.
• Ensure strict compliance with industry standards, regulatory requirements, and organizational policies regarding data management and privacy.

Requirements :

• Bachelor's degree in Life Sciences, Biostatistics, Computer Science, or a related discipline, with a preference for advanced degrees.
• A minimum of years of relevant progressive data management experience in the biotech or pharmaceutical sector.
• Demonstrated proficiency and familiarity with multiple clinical data management platforms.
• Proven experience in managing external CROs and effectively collaborating with diverse, cross-functional teams.
• Deep understanding of clinical trial processes, GCP, and regulatory guidelines pertaining to clinical data management.
• Excellent problem-solving, organizational, and communication skills, paired with the ability to work autonomously and manage multiple priorities in a dynamic environment.
• EDC / CRF development experience preferred.
• Knowledge of CRF design and analytical capabilities.
• Knowledge of CDISC standards and data interchange formats (, SDTM, ADaM).
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA / CFR, ICH / GCP).
• Firm understanding of data privacy and protection regulations (, GDPR).
• Effective communication and interpersonal skills to collaborate with other teams.
30+ days ago