Regulatory and Start-Up Specialist
hace 3 días
Job Overview
We are seeking a highly skilled Regulatory and Start-Up Specialist to join our team at IQVIA. As a key member of our FSP team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines.
Key Responsibilities
• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• 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.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Requirements
• Bachelor's Degree in life sciences.
• +3 years of clinical research experience within regulatory area: submissions, knowledge of ICF, presentations to ethics committee, COFEPRIS.
• Fluent English: written and oral communication skills.
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