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Reg & Start-Up Spec

Aplica ya
Mapa de ubicación: Sofia, Bulgaria Full time R1317490

Descripción del trabajo

Job Overview
Perform 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. May also include maintenance activities.

Essential Functions
• Under general supervision, 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. 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 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, 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.

Qualifications
• Bachelor's Degree Life science-related discipline or professional equivalent Req
• 5 years’ relevant experience including 3 years’ Regulatory and Start-Up experience. Equivalent combination of education, training and experience.
• Good negotiating and communication skills with ability to challenge
• Good interpersonal skills, a strong team player
• Good regulatory and/or technical writing skills
• Thorough understanding of regulated clinical trial environment and knowledge of drug development process
• Proven ability to exercise independent judgment taking calculated risks when making decisions
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Good presentation skills
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Excellent understanding of study financial management 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

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