Remote Regulatory and Site Activation Specialist (German)

IQVIA; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Site Activation professional to manage country-level site activation activities (SA) and related regulatory/document tasks. The role emphasizes working under SOPs, WIs, and project timelines, with focus on accuracy of regulatory materials and timely site activation.

Requirements include a Bachelor’s degree in life sciences and at least 3 years in clinical research or related fields, plus thorough knowledge of GCP/ICH and local regulatory guidelines.

Qualifikationen

• Bachelor’s Degree in life sciences or a related field.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.

Aufgaben

• Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team and other departments.
• Ensure adherence to SOPs, WIs, quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to regulations and SOPs.
• Prepare site regulatory documents and review for completeness and accuracy.
• Maintain internal systems and databases with project-specific information.
• Review project timelines and ensure monitoring measures are in place.

Kenntnisse

GCP/ICH knowledge

Regulatory knowledge

Project coordination

Ausbildung

Bachelor’s degree in life sciences or related field

Jobbeschreibung

IQVIA is seeking a Site Activation professional to manage country-level site activation activities (SA) and related regulatory/document tasks. The role emphasizes working under SOPs, WIs, and project timelines, with focus on accuracy of regulatory materials and timely site activation.

Requirements include a Bachelor’s degree in life sciences and at least 3 years in clinical research or related fields, plus thorough knowledge of GCP/ICH and local regulatory guidelines.