Clinical Operations Leader

6 days ago


Cape Town, Western Cape, South Africa IQVIA Full time

Job Overview

We are seeking a seasoned Clinical Operations Leader to oversee the delivery of site activation, maintenance, and regulatory activities for our clients. In this role, you will be responsible for directing and managing the execution of pre-award activities, scope of work, budget, and resources.

Key Responsibilities:

  • Develop and implement management plans in accordance with project timelines and strategies.
  • Ensure collaboration across departments to deliver project scope within agreed timelines.
  • Create and review technical and administrative documentation to support business development and study initiation.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development and compliance with regulatory requirements.
  • Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance phases.
  • Determine regulatory strategy and parameters for submissions and authorizations.
  • Assess and review the regulatory landscape to provide accurate regulatory intelligence.
  • Execute operational strategy for maintenance of clinical study approvals and contracts.
  • Mentor and coach colleagues as required.

Requirements:

This role requires a Bachelor's Degree in Life Sciences or a related field and 7 years of relevant experience in a scientific or clinical environment. You must have strong negotiation and communication skills, excellent interpersonal skills, and proven ability to work through others to deliver results on complex projects. Proficiency in using systems and technology to achieve work objectives is also essential.

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 create a healthier world.


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