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An established industry player is seeking individuals to join their team in site activation activities. This role involves collaborating with various departments to ensure compliance with regulations and SOPs while preparing and reviewing essential documents. The ideal candidate will have a background in Life Sciences or Law, with a focus on contract negotiation and project management. This position offers a unique opportunity to contribute to the healthcare industry and support the development of innovative medical treatments that improve patient outcomes. If you are passionate about making a difference, this role could be the perfect fit for you.
Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include contract and maintenance activities such as contract amendments negotiation.
Essential Functions
• Perform site activation activities for investigative sites in assigned studies, following regulations, SOPs, and work instructions, in collaboration with the Site Activation Manager (SAM), Project Management team, and other departments. Review documents for completeness, consistency, and accuracy under senior staff guidance.
• Prepare and review site regulatory documents for completeness and accuracy.
• Negotiate budgets and contracts with sites.
• Notify team members upon completion of regulatory and contractual documents for each site.
• Distribute completed documents to sites and project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines, and project plans with accurate project-specific information.
• Review, track, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents.
Qualifications
• Bachelor's Degree in Life Sciences, Law, or related fields.
• Ideally 1 year of experience in a healthcare environment or an equivalent combination of education, training, and experience, with experience in contract negotiation (e.g., CTA amendments) or startup activities. Other administrative experience is highly valued.
• Advanced proficiency in English.
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IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.