Overview
In this role, you will lead site management and monitoring for assigned trials to ensure patient safety and high-quality execution. You will work with cross-functional teams to keep study activities on track from activation to database lock. You will monitor AEs/SAEs and support Drug Safety, audits, and CAPA implementation. This is a remote, Italy-based position within Parexel FSP, offering the chance to contribute to meaningful clinical development across therapeutic areas.
Responsabilità
- Manage site-level activities from activation to database lock to meet timelines and quality expectations
- Oversee site monitoring and close-out to ensure protocol and regulatory compliance
- Coordinate information flow between study team, vendors, and investigator sites
- Monitor AEs/SAEs and collaborate with Drug Safety to resolve required information
- Serve as audit contact and drive CAPA development and checks as needed
Requisiti fondamentali
- Bachelor’s degree in life sciences or equivalent professional life sciences qualification
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
- Minimum 3.5 years of site monitoring experience in clinical research ( Oncology preferred)
- Oncology, Vaccines, Internal Medicine or Infectious Diseases experience preferred
- strong communication and collaboration
- patient-centered mindset
- problem-solving and proactive follow-up
- clinical trial monitoring
- ICH/GCP
- FDA and local regulations
Clinical Research Associate / Senior - FSP - Remote datore di lavoro: Parexel
La nostra azienda è un datore di lavoro eccezionale, offrendo un ambiente di lavoro stimolante e collaborativo per i professionisti delle affari regolatori nel settore dei dispositivi medici. Con opportunità di crescita professionale e un forte impegno per l'innovazione, i dipendenti possono contribuire attivamente a strategie globali mentre lavorano in diverse località europee, sia da casa che in ufficio. Inoltre, la cultura aziendale promuove il supporto reciproco e il miglioramento continuo, rendendo ogni giorno significativo e gratificante.
