Country Activation & Submission Specialist

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

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.