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Clinical Trial Monitor

2 mesi fa


Milano, Lombardia, Italia IQVIA A tempo pieno

Position Overview
Participate in a structured training program designed to equip you with the essential knowledge and skills necessary for conducting independent clinical monitoring visits in alignment with study protocols, standard operating procedures, good clinical practices, and relevant regulatory requirements.

Key Responsibilities

• Complete requisite therapeutic, protocol, and clinical research training to fulfill job responsibilities.

• Acquire hands-on experience in study procedures by collaborating with seasoned clinical personnel.

• Under close supervision, execute site monitoring visits, including selection, initiation, monitoring, and closure, adhering to the contracted scope of work and good clinical practices.

• Provide protocol and related study training to assigned sites while establishing consistent communication channels to manage ongoing project expectations and address issues.

• Under close supervision, assess the quality and integrity of study site practices regarding protocol adherence and compliance with applicable regulations, escalating quality concerns as necessary.

• Oversee the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, as well as data query generation and resolution.

• Ensure that copies or originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulatory standards.

• May assist in the start-up phase under close supervision.

• Maintain accurate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.

• Collaborate and coordinate with study team members to support project execution as necessary.

• If applicable, learn critical aspects for the successful development of project-specific subject recruitment plans at each site. Propose enhancements for site recruitment strategies to align with project objectives and assist in tracking subject recruitment progress.

Qualifications

• Bachelor's Degree in a scientific discipline or healthcare preferred.

• An equivalent combination of education, training, and experience may be accepted in lieu of a degree.

• Possession of the local ministerial decree as per local requirements.

• Prior clinical experience is preferred; some organizations may require two years of clinical experience.

• Proficient in Microsoft Word, Excel, and PowerPoint, along with the use of a laptop and mobile devices.

• Strong written and verbal communication skills, including a good command of the English language.

• Excellent organizational and problem-solving abilities.

• Effective time and financial management skills.

• Ability to establish and maintain productive working relationships with colleagues, managers, and clients.

• Advanced understanding of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Familiarity with protocol requirements as provided in company training.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to pushing the boundaries of human science and data science to make a significant impact in helping our customers create a healthier world.