15 set - Terni
Parexel
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
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