Job Overview
The Sr. Site Activation Lead will be the cornerstone for the team, since this person will be a mentor to the team to clarify doubts about ANVISA and continue to work with ANVISA submissions.

Essential Functions
• Oversee the execution of Feasibility, Site ID, Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Feasibility, Site ID,  Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist functional and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with functional/ regulatory requirements.
• Provide overall  guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
• Identify functional/regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the functional/regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.
• Assume appropriate ownership for strategic initiatives within assigned unit of accountability including recommendation of measures for success.
• Provide support to ensure service offerings meet or exceed customer expectations.
• Collaborate with management and other functional leadership to supprot improved efficiencies, project outcomes and quality metrics for Feasibility, Site ID ana dSite Activation projects.

Qualifications
• Bachelor's Degree Life science-related discipline.
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
• Thispersonneedstohaveexperiencewith ANVISA submissions.

• It's ideal to have experience with advanced therapy, gen therapy, GSTCO, CTNbio.
• Advanced level of English.

#LI-NRJ

#LI-Hybrid (ideally located in Sao Paulo to participate in a forum once a month at the office).

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. Learn more at https://jobs.iqvia.com