Country Study Manager

As Country Study Manager (CSM), you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 

You will be part of an innovative and global Biotechnology company, who pride themselves to be one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today.

• What you will be doing: 

  • Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
  • Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
  • Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
  • Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
  • Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
  • Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
  • Responsible for approval of Baseline and Revised Enrolment Plans (Country Level).
  • Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
  • Translates global start up requirements into local country targets
  • Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
  • Identifies and facilitates resolution of cross-functional study-specific issues.
  • Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
  • Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
  • Collaborates with local teams to ensure country level study delivery is aligned with global expectations.
  • Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactivetimely and solution orientated manner.

You are:

• Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure,
• Minimum 2-3 years’ experience of leading local/regional or global teams 
• Minimum 2-3 years’ clinical trial project management experience
• Minimum 7 years’ 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, etc.)

* All employees must read, write and speak fluent English and host country language.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.