Clinical Data Manager

Werfen • Norcross, GA

5h

About The Position

The Clinical Data Manager is responsible for the design, management, and quality oversight of all clinical study data for clinical performance studies. This role ensures that clinical and laboratory data is collected, validated, and reported in compliance with Good Clinical Practice (GCP), 21 CFR Part 11, IVDR requirements, and internal quality systems. The Clinical Data Manager collaborates across multiple functional teams to ensure data accuracy, completeness and audit readiness for regulatory submissions (510K, IVDR)

Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Data Science, Public Health or related field
• 3-5 years of clinical data management experience in medical devices, diagnostics, or pharmaceuticals.
• Strong understanding of GCP, 21CFR Part 11, and regulatory requirements for IVD clinical studies.
• Proficiency with data analysis tools (SAS, R, Python, or similar).
• Strong analytical skills with exceptional attention to detail.
• Demonstrated ability to work cross-functionally in fast-paced, deadline-driven environments.
• Demonstrated ability to operate in a highly cross functional environment, collaborating effectively across diverse teams and stakeholders
• Proficiency in data cleaning, and query management to ensure high quality, audit ready datasets.
• Strong analytical skills with the ability to manage complex clinical and laboratory data.
• Solid understanding of GCP, 21 CFR Part 11, and IVD regulatory expectations to maintain compliance throughout the data lifecycle.
• Exceptional attention to detail, documentation accuracy, and problem solving skills to identify and resolve data discrepancies.
• Ability to manage multiple priorities and timelines, while maintaining a process driven, quality focused approach.

Responsibilities

• Develop and maintain the Data Management Plan (DMP), data workflows, and data handling procedures.
• Collaborate during protocol development to ensure data requirements are fully defined.
• Develop specifications for data transfers from central labs, reference labs, R&D assay systems, or LIMS platforms.
• Oversee all aspects of clinical data entry, data review, and query management.
• Monitor site and lab data for accuracy, completeness, and protocol compliance.
• Perform routine data reconciliation
• Identify trends, discrepancies, and protocol deviations related to data collection processes.
• Manage data imports and validation for complex laboratory datasets (e.g., method comparison tables/reproducibility studies)
• Work with Biostatistians to generate analysis-ready datasets
• Prepare datasets and workflows for discrepancy resolution and adjudication (if applicable).
• Perform quality checks to ensure traceability and integrity of all analytical datasets.
• Lead database lock activities, ensuring all queries, reconciliations, and audits are complete.
• Provide final cleaned datasets and supporting documentation for regulatory submission
• Assist with preparation of data reports
• Ensure all data systems and processes comply with: GCP (ICH E6 R3) 21 CFR Part 11 FDA IVD guidance EU IVDR Annexes II–XIII CLSI standards and guidelines
• Maintain complete and audit ready documentation within the Quality Management System (QMS).
• Performs other duties and responsibilities as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level