Data Manager

The Global Medical Affairs Biostatistics and Data Management team plays a central role in ensuring high-quality, reliable data supports evidence generation, regulatory submissions, and post-market activities.

We are seeking a highly skilled and motivated Data Manager to support data management processes, workflows, and SOPs within Global Medical Affairs. The Data Manager independently manages data management activities for assigned studies from study planning through database lock, collaborates cross-functionally with Disease State Science, Clinical Research Science, Biostatistics, and external vendors, and ensures high-quality data delivery for global evidence-generation studies.

Primary duties include: 

• 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, REDCap, Castor, Rave) 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 readiness, documentation, and CAPA as needed.
• Contribute to process optimization and development of templates to improve data management efficiency and consistency.
• Ensure data integrity, traceability, and documentation across study artifacts.
• Collaborate cross-functionally (Medical, Clinical Ops, Regulatory, Quality) to align on study objectives and data needs.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications
Required Education, Training, and Experience

• Bachelor’s degree required (Life Sciences, Statistics, Public Health, Health Informatics, or related field).
• 5+ years of professional related experience with clinical data management experience (Medical Affairs/observational preferred).
• Experience with EDC systems and SOP development (Medrio, REDCap, Castor, or Rave; DMP/SOP authoring)

Preferred

• Master’s degree preferred (Life Sciences, Statistics, Public Health, Health Informatics, or related field).
• Experience with real‑world evidence (RWE), registries, or post-market clinical studies.
• Experience in the medical device/diagnostics industry.
• Proficiency with MedDRA and WHODrug coding.
• Vendor oversight experience.
• Familiarity with biostatistics workflows and analysis‑ready data structures.

Knowledge, Skills, and Abilities (KSA)

• 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.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Analyze data and make decisions/recommendations using data to guide decision-making and provide suggestions for improvement.
• Contribute to process improvement by evaluating processes and implementing necessary changes.
• Ability to work cross-functionally allowing for collaboration and communication when working across teams to achieve shared objectives.
• Skilled in MS Office tools including Outlook, Teams, Word, and Excel; advanced skill level.
• EDC design/configuration; data validation planning; query management; coding; UAT/system testing; data transfer specifications; documentation control.
• Knowledge of GCP, GDPR, HIPAA; audit readiness; CAPA management; risk and issue tracking.
• Ability to manage competing deadlines; support publications and dashboards with Biostats.

Supplemental Data

• Primary systems: Medrio, REDCap, Castor, or Rave; ePRO/eCOA platforms; code lists (MedDRA, WHODrug).
• File formats & integrations include CSV/TSV, SAS XPT, and API‑based transfers, secure data repositories.