Regulatory and Start Up Specialist - Medical Devices - France

IQVIA; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Une entreprise leader dans la fourniture de services de recherche clinique recherche un professionnel pour des activités de Site Activation. Le rôle nécessite de travailler avec les sites d'investigation, de garantir la conformité aux procédures standards et d'assurer la qualité des livrables. Une expérience dans le domaine et une maîtrise du français sont essentielles.

Qualifications

• 3 ans d'expérience en recherche clinique.
• Connaissance des procédures et des normes d'entreprise.

Responsabilités

• Servir de point de contact pour les sites d'investigation.
• Préparer les documents réglementaires et assurer leur exactitude.
• Suivre l'évolution des documents réglementaires et éthiques.

Connaissances

Connaissance des systèmes cliniques

Application des directives GCP/ICH

Formation

Baccalauréat en sciences de la vie

Description du poste

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based role requiring submissions experience with MD/IVD and French language fluency.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience
In-depth knowledge of clinical systems, procedures, and corporate standards.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com