The Regulatory and Start-up Manager takes accountability for execution and oversight of local operational clinical trial activities in a country and is able to work on assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Requirements:

• Experience taking ownership of country and site budgets.
• Experience developing, negotiating, and completing Clinical Trial Research .Agreements (CTRAs).
• Experience overseeing and tracking clinical research-related payments.
• Experience with payment reconciliation at study close-out.
• Experience with oversight of FCPA, DPS/OFAC, and maintenance of financial .systems.
• Is able to work on financial forecasting in conjunction with the CRD
• Is able to take responsibility for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Experience developing local language materials including local language Informed Consents and translations.
• Experience interacting with IRB/IEC and Regulatory Authority for assigned protocols.
• Experience managing country deliverable's, timelines, and results for assigned protocols to meet country commitments.
• Is able to take responsibility for quality and compliance in assigned protocols in country.
• Experience contributing to the development of local SOPs.
• Is able to oversee CTCs as applicable.
• Experience coordinating and liaising with study team (CRM, CTC, CRA, Finance, and Legal) to ensure country deliverables are met for submissions, budgets, CTRAs and local milestones.
• Experience collaborating closely with regional operations to align country timelines for assigned protocols.
• Experience providing support and oversight to local vendors as applicable.
• Is able to provide oversight and coordination for local processes.
• Experience with clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
• Experience entering and updating country information in clinical and financial systems

Qualifications:

• B.A./B.S. preferred in Business Finance/ Administration/ Life Science, or equivalent Healthcare related experience
• 5-7 years clinical research experience
• Expertise of core clinical systems, tools and metrics

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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