Carine Malcus

Senior Director, Global Research Compliance @bioMérieux

Lyon, FR
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2024 — Present

Senior Director, Global Research Compliance @bioMérieux

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Leads a team to ensure that our organization adheres to all applicable laws, regulations, and policies in a research context. Is responsible for developing, implementing, and monitoring research compliance programs that help our organization stay within legal and ethical boundaries.Acts as an expert in Bioethics especially for research studies, for access to biological specimens (including biobanking), for access to patient data.

EDUCATION

1991 — 1994

Université Claude Bernard Lyon 1

Ph. D., Génie Biologique et Médical

1990 — 1991

Université Claude Bernard Lyon 1

DEA, GBM

1987 — 1990

ICPI

Ingénieur, Chimie (Immunochimie)

SKILLS

Life SciencesBioethicsBonnes Pratiques CliniquesImmunologyMolecular BiologySopFdaRecherche CliniqueR&DDispositif MédicalSciences De La VieGcpBiotechnologieClinical DevelopmentAnsmPeople ManagementRegulatory AffairsInfectious DiseasesValidationEssais CliniquesMedical DevicesClinical ResearchIvdMaladies InfectieusesHealthcareBiotechnologyRegulationsClinical Trials

ABOUT CARINE MALCUS

Senior Director, Global Research Compliance33 years of experience in biology. 29 years of experience in In Vitro Diagnostic. 24 years of experience in Bioethics. 24 years of experience in clinical trial regulation. 24 years of experience in management. 23 years of experience in multicultural work (including EU, US, Japan, China).Expert in Bioethics (data privacy, clinical trials, research on human beings, sample banks/biobanking.)Expert in IVD clinical trials and IVD regulation.

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