Country Activation and Submission Representative - France

IQVIA; Paris; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

IQVIA seeks a Site Activation Specialist to perform country‑level SA activities in Paris, ensuring compliance with local and international regulations, SOPs, and project timelines.

You will act as SPOC for investigational sites and coordinate regulatory documents, planning, tracking, and quality control across study sites.

The ideal candidate holds a life sciences degree with 3 years of clinical research experience and strong knowledge of GCP/ICH guidelines.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 3 years clinical research or relevant experience.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Understanding of regulated clinical trial environment and drug development.

Responsabilités

• Serve as SPOC for investigative sites, SAMs, PM team, and other departments.
• Ensure adherence to SOPs, work instructions, deliverables, and timelines.
• Perform site activation activities per regulations and SOPs.
• Review and provide feedback on site performance metrics.
• Coordinate regulatory documents and ensure accurate internal records and IP release.

Connaissances

SPOC coordination

GCP/ICH knowledge

Regulatory guidelines knowledge

Project timeline management

Clinical systems knowledge

Formation

Bachelor’s Degree in life sciences or related field

3 years clinical research experience

Outils

Regulatory documents systems

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.

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.

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.
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of 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 help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.