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ICON plc

Senior Project Manager

Posted an hour ago
5-10 years experience
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AI Summary

The Senior Project Manager will lead and coordinate clinical trials from start-up to close-out at a country level, ensuring compliance with ICH-GCP and local regulations. They are responsible for overseeing France-based CRA activities, managing study deliverables, and collaborating with cross-functional stakeholders to ensure projects remain on budget and on schedule.

This is aimed at a Local Trial Manager with strong oversight of France-based CRAs - oncology is a must-have

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.


The Senior PM will work as  Local Trial Manager homebased in France

 

In this role, you will lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations, by keeping quality and scientific integrity of clinical trials at a country level.  In addition, as a Local Trial Manager you will collaborate with cross-functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country. You will be a local/country expert with identifiable project management experience locally.

 

You will be an experienced LTM with solid monitoring visit report review and monitoring visit report approval experience as well as a good track-record of overseeing France-based CRA activities.

 

Key responsibilities include;

  • Planning, management and oversight of clinical study execution
  • Accountable for study deliverables in that country
  • Leads country-level operational planning and supports site selection
  • Ensure key stakeholders are kept informed of study progress e.g. global leads, global clinical project managers, etc. and provides country level input
  • Ensure effective study risk management
  • Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
  • Contribute to, deliver and/or lead staff training
  • Oversight and monitoring of applicable vendor activities
  • Identifying risk, implementing risk mitigation strategies and resolving issues at a country/site level and leading and continually reviewing country level risk mitigation activities to ensure study delivery to plan
  • Contributes to the study-level forecast
  • Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
  • Monitors country enrolment and retention,  and  act  on  deviations  from  plan.  Identify barriers to enrolment and support recruitment and retention strategic solutions.
  • Reviews and approved Monitoring Visit Reports.
  • May provide updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).

 

You will need:

  • Ideally BA/BS/BSc preferred
  • Ideally at least 3-5 years’ clinical trial management experience with oversight of France-based CRAs
  • Must have oncology clinical research industry experience
  • Ideally solid work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors,
  • Flexible, collaborative, positive mindset within a fast-moving work environment

 

#LI-Remote:

#LI-ET1 


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

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