Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites,
Ensure adherence to Standard Operation Procedures (SOPs), work instructions (WIs), quality of designated deliverables and project timelines.
Perform Regulatory Start-up and Maintenance activities according to applicable regulations, SOPs and WIs.
Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Review, prepare and negotiate site contracts and budgets with sites.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP release documents in line with project timelines.
Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
Perform quality control documents provided by sites.
May have direct contact with Sponsor on specific initiatives.
May perform Site Selection Visits if a trained monitor.
May participate in feasibility and/or site identification activities.
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
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