Clinical Data Manager

Werfen•Norcross, GA

22h

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.

Responsibilities

Study Planning & Database Development
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.
Data Collection & Data Cleaning
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.
Data Integration & Analysis Preparation
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.
Database Lock & Regulatory Submission Support
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
Quality & Compliance
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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.