Clinical Data Manager

About the Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

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)

Key Accountabilities

• 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 Biostatisticians 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.

Networking/Key relationships

• Work closely and collaboratively with all members of clinical affairs (CRA)
• Interface regularly with cross functional teams (R&D, Regulatory) as well as other functions across the organization as needed

Minimum Knowledge & Experience required for the position:

• 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, 21
  
  CFR 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.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• 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.

Travel requirements:None

Werfen is an Equal Opportunity…