Senior Country Site Activation Lead

2 semanas atrás

São Paulo, São Paulo, Brasil Iqvia Tempo inteiro
Job Overview

As a Senior Country Site Activation Lead at IQVIA, you will be responsible for overseeing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources.

You will lead strategic initiatives and work with senior management across disciplines to develop implementation plans. This role requires a seasoned professional with minimal supervision, who can mentor and coach newer team members.

Key Responsibilities
  • Oversee the execution of feasibility, site ID, site activation, and maintenance for assigned projects in accordance with the agreed RSU site activation strategy.
  • Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.
  • Ensure collaboration across feasibility, site ID, regulatory, and site activation, including communication with regions and countries, to successfully deliver the agreed project scope.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance.
  • Provide specialist functional and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials.
  • Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase.
  • 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.
  • 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.
  • Mentor and coach colleagues as required.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project-specific information.
Requirements
  • Bachelor's Degree in a Life science-related discipline.
  • 7 years' relevant experience in a scientific or clinical environment, including demonstrable experience in an international role.
  • Thorough understanding of regulated clinical trial environment and knowledge of drug development process.
  • Advanced level of English.

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