Clinical Data Manager

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 7000 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. Were 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 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 IIXIII
    • 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 crossfunctional teams (R&DRegulatory) as well as other functions across the organization as needed

Minimum Knowledge & Experience required for the position:

• Bachelors 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.

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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.