Perform site monitoring visits in accordance with contracted scope of work
Collaborate with cross-functional teams and CRAs to maintain high standards
Conducts investigational product inventory and accountability
Reviews the Investigator Site File for audit readiness
Prepares accurate monitoring visit reports and communication logs
Provides guidance, oversight, and feedback to the study team
Oversee Clinical Research Associates to ensure monitoring visits are conducted within timelines

Requirements

Bachelor’s degree in a relevant field (sciences, nursing, medical preferred)
Preferred 7+ years’ experience in the clinical research or health industry fields
Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries
People and study management experience required
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools
Strong command of English, and the local language as necessary, both written and verbal.
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.

Benefits

Professional development
Global travel
Flexible work programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringdata managementsite managementmonitoring visit reportsinvestigational product inventoryaudit readinessclinical trial softwareISO 14155ICH GCP

Soft Skills

collaborationguidanceoversightfeedbackcommunicationpeople managementstudy management