Study Start Up Manager

ICON plcBlue Bell, SD
Remote

About The Position

Study Start Up Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Study Start Up Manager at ICON, you will lead and oversee the start-up activities for clinical trials, ensuring that all processes are completed efficiently and in compliance with regulatory requirements.

Requirements

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
  • Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment.
  • Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously.
  • Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams.
  • Experience with process optimization and implementing best practices in study start-up activities.
  • Willingness to travel as required (approximately 25%)
  • Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

  • Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
  • Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
  • Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
  • Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
  • Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
  • Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways
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