Remote Regulatory & Site Activation Specialist (Vienna)

IQVIA LLC; Wien; Vor Ort; EUR 50.000 - 75.000; Vollzeit

Zusammenfassung

IQVIA LLC is seeking a Regulatory and Start Up Specialist for Austria. The home-based role requires fluency in German and coordination of site activation activities at the country level in line with SOPs and regulatory guidelines.

The role involves preparing regulatory documents, maintaining project databases, and providing local expertise to SAMs and teams to ensure timelines are met. A life sciences degree with clinical research exposure is essential.

Qualifikationen

• Bachelor’s Degree in life sciences or related field with 3 years’ clinical research experience.
• In‑depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge of GCP/ICH and applicable regulatory guidelines.
• Understanding of regulated clinical trial environment and drug development process.

Aufgaben

• Serve as SPOC for investigative sites and project teams.
• Perform site activation activities per regulations and SOPs.
• Prepare and review site regulatory documents for completeness.
• Maintain internal systems and tracking tools with project data.
• Provide regulatory input during project timelines.

Kenntnisse

Regulatory affairs

Clinical research

GCP/ICH

Documentation

SOP compliance

Ausbildung

Bachelor’s Degree in life sciences

Tools

Regulatory databases

Jobbeschreibung

IQVIA LLC is seeking a Regulatory and Start Up Specialist for Austria. The home-based role requires fluency in German and coordination of site activation activities at the country level in line with SOPs and regulatory guidelines.

The role involves preparing regulatory documents, maintaining project databases, and providing local expertise to SAMs and teams to ensure timelines are met. A life sciences degree with clinical research exposure is essential.