Site Activation Manager at IQVIA overseeing site activation and regulatory activities for clinical studies. Ensuring compliance with project plans and mentoring colleagues.
Responsibilities
Direct and manage all site activation activities.
Oversee the execution of Site Activation strategy.
Develop and maintain Management Plans.
Ensure compliance with RSU Management Plan.
Create and review necessary documentation.
Provide support for clinical trials.
Mentor and coach colleagues when needed.
Maintain internal systems for project tracking.
Requirements
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Oversee the execution of Site Activation and/or Maintenance for assigned projects.
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan.
Ensure collaboration across Regulatory & Site Activation.
Create and/or review technical and administrative documentation.
Provide overall guidance and oversight of multi-regional and multi-protocol programs.
Determine regulatory strategy and parameters for submissions.
Assess and review the regulatory landscape.
Ensure appropriate quality standards during site activation.
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