Senior Regulatory Specialist
hace 2 semanas
The Senior Regulatory and Start Up Specialist 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. This role may also include maintenance activities.
Key Responsibilities- Under general supervision, serve as the Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
- 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.
- Review, establish, and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
- 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.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- Bachelor's Degree in life sciences.
- +3 years of clinical research experience within the regulatory area in Argentina:
- Local submissions
- ICF customization (site and country level)
- Presentations to ethics committees & ANMAT.
• Fluent English: written and oral communication skills
• Ability to work independently
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 #J-18808-Ljbffr
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