Regulatory and Start Up Specialist

IQVIA; Paris; Hybride; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Une entreprise leader dans la recherche clinique cherche un(e) professionnel(le) pour des fonctions d'activation de site. Ce rôle hybride nécessite une expertise en systèmes cliniques et une expérience significative en recherche clinique. Le candidat idéal doit posséder un baccalauréat en sciences de la vie, parler couramment français et avoir la capacité de travailler en équipe tout en gérant des projets avec divers interlocuteurs.

Qualifications

• Minimum 3 ans d'expérience en recherche clinique ou expérience pertinente.
• Maîtrise des normes de recherche clinique et des procédures.

Responsabilités

• Agir comme point de contact unique pour les études assignées.
• S'assurer du respect des normes et des délais du projet.
• Préparer et examiner les documents réglementaires pour précision.

Connaissances

Connaissance des systèmes cliniques

Application des lignes directrices GCP/ICH

Compréhension des exigences réglementaires

Formation

Baccalauréat en sciences de la vie ou domaine connexe

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) for assigned studies, liaising with investigative sites, Site Activation Managers (SAM), Project Management team, and other departments as necessary.

Ensure adherence to SOPs, Work Instructions (WIs), quality standards, and project timelines.
Perform site start-up and activation activities following applicable regulations, SOPs, and work instructions.

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

Implement monitoring measures and contingency plans as needed.
Notify team members upon completion of regulatory and contractual documents for each site.
Track and follow up on the progress, approval, and execution of documents such as regulatory submissions, ethics approvals, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents, ensuring alignment with project timelines.
Provide local expertise to SAMs and project teams during project planning.
Perform quality control of documents provided by sites.
May have direct communication with sponsors for specific initiatives.

Qualifications

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

• Deep knowledge of clinical systems, procedures, and corporate standards.
• Ability to apply GCP/ICH and applicable regulatory guidelines.
• Understanding of regulatory requirements, including local regulations, SOPs, and company standards.
• Knowledge of the regulated 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 intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com