Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.

• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.

• Evaluate the quality and integrity of study site practices; Escalate quality issues as appropriate.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.

• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans

• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.

• Requires at least 1 year of on-site monitoring experience.

• Equivalent combination of education, training and experience may be accepted in lieu of degree.

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).

• Good therapeutic and protocol knowledge as provided in company training.

• Written and verbal communication skills including good command of English language.

• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com