Remote Clinical Data & Quality Lead

Resilience Care; France; A distancia; EUR 75.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work from France

Agile team structure

Internal company events

Descripción de la vacante

Resilience Care, a French company delivering remote medical monitoring, seeks a senior GCP compliance professional for QARA. You will oversee regulatory compliance across sponsored studies and partner collaborations, ensuring data integrity and system qualification.

You’ll work with diverse teams to embed quality into data workflows. You will oversee deviations, audits, inspections, and TMF reviews, aiming for inspection readiness while collaborating with DPO, CROs and partners.

Formación

• Apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to clinical studies and systems.
• Manage deviations, CAPAs, audits and inspection preparation beyond data cleaning.
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles.
• Work with EDC systems and ePRO/eCOA solutions, translating requirements into controls.
• Fluent in English; strong communication and training abilities.

Responsabilidades

• Oversee study GCP compliance, manage deviations and CAPAs, and conduct TMF reviews.
• Maintain inspection readiness and CRO oversight per ICH E6(R3).
• Qualify systems, review data extracts, audit trails and DM plans.
• Collaborate with Data and Clinical teams to embed compliance in data workflows.
• Maintain clinical quality procedures and monitor regulatory developments.

Conocimientos

GCP compliance

Quality management

CSV/CSQ qualification

EDC/ePRO knowledge

Regulatory documentation

Herramientas

Medidata Rave

Veeva

Oracle EDC

Descripción del empleo

Resilience Care, a French company delivering remote medical monitoring, seeks a senior GCP compliance professional for QARA. You will oversee regulatory compliance across sponsored studies and partner collaborations, ensuring data integrity and system qualification.

You’ll work with diverse teams to embed quality into data workflows. You will oversee deviations, audits, inspections, and TMF reviews, aiming for inspection readiness while collaborating with DPO, CROs and partners.