Study Start Up Manager

hace 7 días


Xico, México Icon Plc A tiempo completo

About the Role:

As a Study Start Up Manager at ICON Plc, you will play a critical role in ensuring the successful preparation, review, and approval of study master, country-related, and site-level informed consent documents. Your expertise in clinical research operations will be instrumental in coordinating and leading a team of Study Start Up Associates, driving process improvements, and ensuring quality optimization, efficiency, and cost containment.

Key Responsibilities:

  • Lead a team of Study Start Up Associates in the preparation, review, and approval of informed consent forms and related documentation.
  • Mentor and develop team members to ensure quality and alignment of processes.
  • Build and negotiate processes with sponsors and portfolio directors.
  • Deliver training to team members and global study teams to ensure quality and alignment of processes.
  • Continually assess opportunities for process improvements and develop and monitor process change implementation.
  • Provide financial oversight to ensure appropriate profitability and monitor and manage staff workload to optimize resource utilization.

Requirements:

  • Education: Degree in Life Sciences.
  • Proven clinical research industry experience.
  • In-depth knowledge of informed consent procedures from a regulatory perspective.
  • Significant experience in the preparation, review, and approval of study master, country-related, and site-level informed consent documents.
  • Effective prioritization skills and ability to multi-task with meticulous attention to detail.
  • Strong mentoring skills, team management, and team leadership.
  • Excellent interpersonal skills, including negotiation and communication.

About ICON Plc:

ICON Plc is a world-leading healthcare intelligence and clinical research organization. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. We are committed to developing our employees in a continuous learning culture, providing a comprehensive and competitive total reward package, and promoting a workplace free of discrimination and harassment.



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