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ICON plc

Clinical Trial Manager

Reposted 10 Days Ago
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In-Office
Sydney, New South Wales, AUS
Expert/Leader
In-Office
Sydney, New South Wales, AUS
Expert/Leader
Oversee clinical trial workstreams from design through execution, ensuring regulatory compliance, quality, and timelines. Manage cross-functional collaboration, enrollment, protocols, trial operations, data analysis, stakeholder communication, and issue resolution. The role requires extensive clinical trial management experience, strong analytical and organizational skills, team development capabilities, and approximately 25% travel.
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Clinical Trial Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.


As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.


As a Clinical Trial Manager (role: Study Start Up Manager) at ICON, you will be responsible for study planning, SSU activities and activation deliverables of assigned projects in compliance with ICON processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.  In satellite countries acts as primary back-up and deputy of the country manager. 


Your Profile:

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:

  • Bachelor's degree in a relevant field
  • 7 years clinical research experience in a CRO or Pharma setting
  • >  3 years working in Study Start Up including:

- SSU strategy in close collaboration with Study Start-Up Team

- SSU timelines and deliverables are met according to country

commitments 

- Timely start-up activities from country allocation until Green Light

(ready to initiate site millstone) in assigned projects 

- Close collaboration with local IRBs/IECs and Health Authorities, as

applicable 

- Study start-up activities are conducted and completed on time,

including preparation of IRB/IEC submission packages, review of

Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for

Health Authorities submissions, as required 

- Prepares and finalizes local submission package for submission to

IRB/IEC, CTA Hub as well as Health Authorities

- Leads site selection in collaboration with local and global

stakeholders

- Experience managing outsourced studies to CROs


#LI-DP1


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 careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.


Are you a current ICON Employee? Please click here to apply

ICON plc Sydney, New South Wales, AUS Office

Wallumedegal Country, 2 Lyon Park Road, North Ryde, Sydney, New South Wales, Australia, 2113

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