Remote Study Start-Up & Site Activation Specialist

IQVIA; Zaventem; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

IQVIA is seeking a Site Activation professional to drive country-level site startup activities and regulatory documentation in a home-based role. You will collaborate with SAMs, PMs, and other departments to ensure timely activation of investigative sites in accordance with SOPs and regulatory guidelines.

Fluency in Dutch/French/English is required along with local submissions experience. The role requires a life sciences degree and at least 3 years in clinical research or related fields, with

Qualifications

• Bachelor's degree in life sciences or related field.
• 3 years' clinical research or other relevant experience.
• Ability to manage multiple projects.
• Knowledge of GCP/ICH and regulatory guidelines.

Responsabilités

• Serve as SPOC in assigned studies for sites, SAM, PM team, and other departments as necessary.
• Ensure adherence to SOPs, WIs, quality of deliverables and project timelines.
• Perform site startup and activation activities according to regulations and SOPs.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project information.
• Review and provide feedback on site performance metrics.
• Plan and agree on project timelines with teams.
• Ensure monitoring measures and contingency plans are in place.

Connaissances

Project management

GCP/ICH knowledge

Regulatory guidelines

Clinical trial knowledge

Formation

Bachelor's degree in life sciences

Description du poste

IQVIA is seeking a Site Activation professional to drive country-level site startup activities and regulatory documentation in a home-based role. You will collaborate with SAMs, PMs, and other departments to ensure timely activation of investigative sites in accordance with SOPs and regulatory guidelines.

Fluency in Dutch/French/English is required along with local submissions experience. The role requires a life sciences degree and at least 3 years in clinical research or related fields, with