ICON plc

Manager of Study Start Up

ICON plc$90K — $120K *
US-AnywhereRemote in Blue Bell, PA
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Extensive experience in clinical trial study start-up and global regulatory requirements
  • Proven leadership skills with team management experience
  • Excellent organizational and project management skills
  • Strong communication and stakeholder management abilities
  • Experience in process optimization and best practices implementation
  • Willingness to travel approximately 25% of the time

Responsibilities

  • Manage the end-to-end study start-up process including site identification and regulatory submissions
  • Lead a team of study start-up professionals, providing guidance and mentorship
  • Collaborate with sponsors and internal teams to ensure compliance with regulations and timelines
  • Monitor study start-up metrics, timelines, and budgets for timely project delivery
  • Identify potential risks in the start-up process and implement mitigation strategies
  • Drive continuous improvement initiatives to optimize the study start-up process

Benefits

  • Comprehensive total rewards package for health and wellbeing
  • Health programmes including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training
Full Job Description
Manager of Study Start Up

As a Manager, Study Start Up 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.

What You Will Do:

You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.

Key responsibilities include:

  • 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.

Your Profile:

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

  • 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.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • 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

Benefits may vary depending on role and location.


Visit our to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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