Regulatory and Site Activation Manager

hace 5 días

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

As a Regulatory and Site Activation Manager at Iqvia Argentina, you will play a critical role in the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. Your expertise will be essential in overseeing the execution of site activation and maintenance, developing and implementing management plans, and ensuring collaboration across regulatory and site activation teams.

Key Responsibilities
  • Oversee the execution of site activation and maintenance for assigned projects, adhering to project timelines and regulatory requirements.
  • Develop and implement management plans according to the scope of work and project plan, resolving project-related issues as needed.
  • Ensure collaboration across regulatory and site activation teams, including communication with regions and countries, to successfully deliver the agreed project scope.
  • Create and review technical and administrative documentation to support business development and enable study initiation and maintenance.
  • Provide specialist regulatory 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 and expectations 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.
  • Execute operational strategy and 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 and maintenance.
  • Mentor and coach colleagues as needed.
  • 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 related field.
  • 6 years of clinical research experience, including 3 years 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.

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