Description

Position Summary
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 establish foundational data management processes, workflows, and SOPs within Global Medical Affairs. The Data Manager will independently lead data management activities from study planning through database lock; collaborates with Disease State Science, Clinical Research Science, Biostatistics, and external vendors; ensures high-quality data delivery for global evidence-generation studies.

Primary Duties

• Lead end-to-end data management for Medical Affairs evidence-generation projects from start-up through database lock.
• Develop and maintain data standards, data dictionaries, and controlled terminologies for consistency across studies.
• Author Data Management Plans (DMPs), CRF/eCRF specifications, and edit checks/validation plans.
• Ensure compliant data collection, handling, and privacy aligned with GCP, GDPR, and HIPAA.
• Manage data vendors and EDC providers (e.g., Medrio, REDCap, Castor, Rave), including 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.
• Define and manage data transfer specifications and secure data pipelines with IT/Data Engineering.
• Track timelines/metrics, drive issue resolution, and communicate risks and mitigations 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 templates to scale the GMA data management function.
• Champion data integrity, traceability, and documentation across all 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

• Master'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

• 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.
• Driving continuous improvement by evaluating processes and implementing necessary changes.
• Ability to work cross-functionally allowing for better 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.

Working Conditions & Physical Requirements

• Ability to remain in a stationary position (sitting or standing) for prolonged periods.
  Ability to ascend/descend stairs, ladders, ramps.
  Standard office environment with extended screen time.
  Ability to attend early/late global meetings.
  No PPE requirement.
  No heavy lifting or machinery operation required.

Travel Requirements

• Domestic travel: 5%
  International travel: 0

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).