Regulatory and Site Activation Manager

3 weeks ago


Cape Town, Western Cape, South Africa IQVIA Full time

Job Overview:

As a key member of our team at IQVIA, the Regulatory and Site Activation Manager will be responsible for the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This role will oversee the execution of site activation and maintenance, ensuring adherence to project timelines and regulatory requirements.

Key Responsibilities:

  • Develop and implement the Management Plan according to the Scope of Work and Project Plan, resolving project-related issues where necessary.
  • Collaborate with regulatory and site activation teams to ensure successful delivery of project scope, in compliance with the RSU Management Plan.
  • Provide regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, while ensuring compliance with regulatory requirements.
  • Identify regulatory complexity and challenges, offering creative and practical solutions to support the bid process and site activation plan.
  • Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations, and review/ negotiation of contracts and essential documents.

Qualifications:

  • Bachelor's Degree in Life Sciences or related field.
  • 7 years' relevant experience in a scientific or clinical environment, including international roles.
  • Strong negotiation and communication skills, with ability to challenge.
  • Excellent interpersonal skills and strong team player.
  • Proven ability to work through others to deliver results to appropriate quality and timeline metrics on complex projects.


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