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QIMA

Quality control, auditing, testing, and compliance

Data Manager / IT Developer - CSV in Clinical Research

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNice, France€32k /yrIn-person

About the Job

Requirements

  • Master the full data management cycle, from CRF design through database lock.
  • Configure and validate data collection and data validation tools.
  • Apply CDISC, ICH, GDPR (RGPD), and good clinical practice standards.
  • Ensure database consistency, security, and compliance.
  • Conduct impact analyses and consistency reviews.
  • Use SQL for data processing and validation, as well as PHP and jQuery.
  • Have knowledge of generative AI, including LLM API integration and automation.
  • Organize documentation and archiving in an audited environment.
  • Communicate effectively in English, both orally and in writing.
  • Demonstrate rigor, attention to detail, autonomy, analytical and synthesis skills, the ability to work in project mode and multidisciplinary teams, clear communication and teaching ability, confidentiality, and responsibility.

Responsibilities

  • Set up data collection tools to structure and ensure the quality and integrity of data from clinical studies.
  • Design and administer clinical databases, including case report forms, consistency checks, query management, and database lock.
  • Implement, maintain, and validate data collection systems, including eCRFs, databases, servers, and interfaces.
  • Apply operational data security and traceability practices in accordance with CNIL, GDPR, MR-001, ANSM, 21 CFR Part 11, and ICH requirements, coordinating with the DPO on regulatory and legal matters.
  • Contribute to data standardization using CDISC and SDTM.
  • Monitor technological and regulatory developments in the relevant tools and standards.
  • Coordinate with group IT teams to deploy, maintain, and secure tools.
  • Manage the secure server environment and access to internal IT, quality, and data resources.
  • Ensure the technical compliance of infrastructure and tools with group standards.
  • Configure, validate, and evolve business tools used by QIMA Skinpharma, including eCRF/EDC, CTMS, and management, activity-tracking, or other internal software as needed.
  • Support and maintain the organization’s business software.
  • Improve tools continuously according to operational needs across clinical, management, quality, and other areas.
  • Develop data collection systems from a legacy system.
  • Gather requirements in cooperation with operational teams.
  • Explore and integrate AI solutions for automation, document extraction and structuring, and decision support.
  • Document and validate developed solutions, including specifications and tests, in accordance with GAMP 5 and 21 CFR Part 11.
  • Apply knowledge of computer system validation (CSV).

About the Company

QIMA

Quality control, auditing, testing, and compliance

QIMA provides quality control and compliance services to brands, retailers, and importers. It offers inspection, auditing, and testing to ensure product safety, supplier performance, and regulatory compliance across manufacturing facilities worldwide. The services translate into real-time supply chain intelligence that helps clients monitor and improve quality and ESG-related outcomes, with fees-based revenue supported by accreditation from regulatory bodies and international standards. Unlike firms that offer only one aspect of QA, QIMA combines multiple assurance activities with a trusted, accredited framework and simple, client-focused service to give end-to-end visibility and control over supplier performance. The company’s goal is to help clients produce trustworthy products while prioritizing client satisfaction, integrity, and simplicity in operations.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Hong Kong
Founded
2005

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