Senior Clinical Trial Monitor – Hybrid/Remote

CTI Clinical Trial and Consulting Services; Riyadh Region; On-site; SAR 120,000 - 180,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a capable clinical trial monitor in Saudi Arabia to oversee monitoring activities from Phase I to IV and Real World Evidence studies. You will develop knowledge of drug development, ICH GCP, and regulatory guidelines while managing study site activities in line with SOPs.

Responsibilities include conducting site visits, collecting and tracking regulatory documents, supporting start-up activities, and coordinating with sponsors and project

Qualifications

• Minimum 1 year of clinical trial monitoring experience or equivalent as determined by CTI Management and HR.
• Bachelor's degree or higher in allied health field or RN with relevant qualifications; nursing diploma with experience acceptable.
• Experience in hospital, CRO, or pharmaceutical settings handling clinical research activities.

Responsibilities

• Serve as main CTI contact for assigned study sites and manage monitoring visits (PSV, SIV, IMV, COV).
• Complete site visit deliverables within Monitoring Plan timelines, adhering to SOPs and ICH GCP.
• Assist with study start-up, including feasibility, pre-study activities and site selection.
• Collect, review, and track essential regulatory documents and training.
• Participate in investigator, client and project team meetings; support CRF development as needed.
• Ensure proper storage, dispensation and accountability of Investigational Product and trial materials.
• Liaise with Data Management for data cleaning and site status updates to the Clinical Project Manager.
• Support regulatory affairs, ethics submissions, and site payments; manage ISF and TMF per SOPs.

Skills

Clinical trial monitoring

Regulatory compliance knowledge

Study coordination

Education

Bachelor's degree or higher in allied health field such as nursing, pharmacy, or health/science

Job description

CTI Clinical Trial and Consulting Services is seeking a capable clinical trial monitor in Saudi Arabia to oversee monitoring activities from Phase I to IV and Real World Evidence studies. You will develop knowledge of drug development, ICH GCP, and regulatory guidelines while managing study site activities in line with SOPs.

Responsibilities include conducting site visits, collecting and tracking regulatory documents, supporting start-up activities, and coordinating with sponsors and project