14 set - Sassari
Parexel
OverviewIn 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.
ResponsabilitàManage 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 fondamentaliBachelor'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
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