Regulatory and Start Up Specialist

IQVIA; Courbevoie; Hybride; EUR 40 000 - 55 000; Plein temps

Résumé du poste

Une société leader dans les services de recherche clinique recherche un SPOC pour gérer les activités d'activation de sites. Le rôle exige de superviser l'adhésion aux procédures et de coordonner avec les parties prenantes. Le candidat idéal a un baccalauréat en sciences de la vie et 3 ans d'expérience en recherche clinique, avec une connaissance approfondie des normes réglementaires et des procédures opérationnelles standard.

Qualifications

• Expérience de 3 ans dans la recherche clinique ou un domaine similaire.
• Capacité à appliquer des directives réglementaires et SOPs.
• Compréhension approfondie de l'environnement d'essai clinique.

Responsabilités

• Agir en tant que point de contact pour les sites d'investigation assignés.
• Assurer le respect des procédures opérationnelles standard et des délais.
• Préparer et examiner des documents réglementaires pour les sites.

Connaissances

Connaissance des systèmes cliniques

Application des directives GCP/ICH

Compréhension du processus de développement de médicaments

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.

Hybrid role, 3 days a week in the office. French language fluency required.

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 SOPs, Work Instructions (WIs), quality of deliverables, and project timelines.
Perform start-up and site activation activities according to regulations, SOPs, and work instructions.

Distribute completed documents to sites and internal team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Maintain accurate records in internal systems, databases, and tracking tools.
Review and provide feedback on site performance metrics.
Coordinate project planning and timelines with team members.

Implement monitoring measures and contingency plans as needed.
Update team on regulatory and contractual document completion.
Track and follow up on document progress, approvals, and releases, aligning with project timelines.
Provide local expertise during project planning.
Perform quality control of site-provided documents.
May communicate directly with sponsors on specific initiatives.

Qualifications

Bachelor's Degree in life sciences or a related field, with 3 years of clinical research or relevant experience; or equivalent education, training, and experience.

• Deep knowledge of clinical systems, procedures, and standards.
• Ability to apply GCP/ICH and regulatory guidelines.
• Knowledge of regulatory requirements, SOPs, and corporate standards.
• Understanding of the clinical trial environment and drug development process.

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