Data Manager - Medical Affairs

BioMerieux · Étoile-sur-Rhône

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A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

What will be your main accountabilities?

Reporting to the VP Medical Biostats and Data Management, you will support data management processes, workflows, and SOPs, and ensure high-quality data delivery, reliable data supports evidence generation, regulatory submissions, and post-market activities.

Primary Duties:

• Manage end-to-end data management activities for Medical Affairs evidence-generation projects from start-up through database lock, working independently with limited supervision
• Develop and maintain study-level data standards, data dictionaries, and controlled terminologies, contributing to consistency across studies
• Author Data Management Plans (DMPs), CRF/eCRF specifications, and edit checks/validation plans for assigned studies
• Ensure compliant data collection, handling, and privacy for assigned studies in alignment with GCP, GDPR, and HIPAA requirements
• Work with data vendors and EDC providers (e.g., Medrio) to support UAT and system configuration.
• Perform ongoing data review, discrepancy management, and reconciliation with external data sources
• Collaborate with data engineers for automated data pipeline development
• Develop and maintain data transfer specifications for assigned studies in collaboration with IT/Data Engineering, supporting secure data pipeline operations
• Track timelines and metrics, support issue resolution, and communicate risks and mitigation plans to stakeholders
• Deliver clean, analysis-ready datasets to Biostatistics for reports, publications, and dashboards.
• Support audit/inspection of readiness, documentation, and CAPA as needed
• Contribute to process optimization and development of templates to improve data management efficiency and consistency
• Collaborate cross-functionally (Medical, Clinical Ops, Regulatory, Quality).

What is your profile?

• Master's degree preferred in Life Sciences, Statistics, Public Health, Health Informatics, with 5+ years of Clinical data management experience (Medical Affairs/observational preferred) in the medical device/diagnostics industry
• Experience with EDC systems and SOP development (Medrio, REDCap, Castor, or Rave; DMP/SOP authoring)
• Experience with real-world evidence (RWE), registries, or post-market clinical studies
• Familiarity with biostatistics workflows and analysis-ready data structures
• Knowledge of GCP, GDPR, HIPAA; audit readiness; CAPA management; risk and issue tracking

Skills and abilities:

• Acting with honor and being open, consistently upholds and reflects the core ethical principles and values that bioMérieux promotes
• Written communications, including the ability to communicate technical data in written form
• Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement
• Ability to work cross-functionally, allowing for better collaboration and communication when working across teams to achieve shared objectives

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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