Clinical Trial Monitoring Specialist

1 settimana fa

Milano, Lombardia, Italia IQVIA A tempo pieno

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

Key Responsibilities

• Complete necessary therapeutic, protocol, and clinical research training to effectively perform job responsibilities.

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

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

• Under guidance, provide protocol and related study training to assigned sites, establishing consistent communication to manage project expectations and address issues.

• Evaluate the quality and integrity of site practices concerning protocol adherence and applicable regulations, escalating quality concerns as necessary.

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

• Ensure that copies or originals of site documents are properly filed in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) complies with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulatory requirements.

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

• Maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports and generating follow-up correspondence.

• Collaborate with study team members to support project execution as needed.

• If applicable, learn key aspects for the successful development of project-specific subject recruitment plans, suggesting improvements to enhance predictability and assist in tracking recruitment progress.

Qualifications

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

• Equivalent combinations of education, training, and experience may be considered in lieu of a degree.

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

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

• Proficient in Microsoft Word, Excel, PowerPoint, and familiar with laptop and mobile devices.

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

• Excellent organizational and problem-solving abilities.

• Effective time and financial management skills.

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

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

• Familiarity with applicable protocol requirements as outlined in company training.

IQVIA is a premier global provider of advanced analytics, technology solutions, and clinical research services to the life sciences sector. We are committed to pushing the boundaries of human science and data science to create a significant impact, helping our clients foster a healthier world.

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