Regulatory and Site Activation Manager

hace 4 semanas

Madrid, Madrid, España Iqvia Argentina A tiempo completo
Job Overview

As a Regulatory and Site Activation Manager, you will be responsible for directing and managing the delivery of all required 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.

Global experience and exposure are required for this role.

Key Responsibilities
  • Oversee the execution of 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 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 regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst enabling compliance with 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 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 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.
Requirements
  • Bachelor's Degree in a related field
  • 6 years of clinical research experience, including 3 years' experience in a leadership capacity
  • Equivalent combination of education, training, and experience
  • Full knowledge of drug development process
  • Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards
  • Strong knowledge of budget management and resourcing
  • Considerable working knowledge of medical terminology
  • Strong knowledge of Microsoft Office and e-mail applications
  • Effective communication, organizational, interpersonal, and leadership skills
  • Strong negotiation skills
  • Ability to independently coordinate and manage new processes
  • Ability to lead and motivate teams
  • Ability to handle management/personnel issues
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work well within a matrix team environment
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
About Us

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.

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