Regulatory and Clinical Trial Manager

3 weeks ago

Durham, North Carolina, United States IQVIA, Inc. Full time
Job Overview

As a Regulatory and Clinical Trial Manager at IQVIA, Inc., 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. You will 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. Your collaboration across Regulatory & Site Activation, including communication with regions and countries, will be crucial in successfully delivering the agreed project scope in compliance with the RSU Management Plan. You will create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Additionally, you will provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, while enabling compliance with regulatory requirements. You will also provide overall guidance and oversight of multi-regional and multi-protocol programs during the initial start-up and maintenance phase as an integral member of the study management team. You will determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.

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.
  • Collaborate 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, while enabling compliance with regulatory requirements.
  • Provide overall guidance and oversight of multi-regional and multi-protocol programs during the 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.


Requirements

  • Bachelor's Degree in a related field.
  • 6 years of clinical research experience, including 3 years of experience in a leadership capacity.
  • Full knowledge of the 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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