Description

ICON has opened a new Clinical Study Operations Manager (US Clinical Trial Manager) position running clinical trials (Located in Canada – running trials in the US). It is a full time, no travel, fully remote, full benefits direct hire position with starting pays up to $150k Canadian (No bonus).

Please let me know if you are currently running trials in the US and interested in finding out more about it.

A Clinical Study Operations Manager (US Clinical Trial Manager), is in charge of the US trial deliverable, working with cross functional teams, trial budget and trials Vendors, reviewing trip reports, following monitoring plan as well as site and CRA interaction.

What You Will Be Doing:

  • Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
  • May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
  • Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
  • Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
  • Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
  • Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
  • Ensures compliance to relevant Global and Local, internal and external requirements and regulations

What you need to have:

  • A scientific or technical degree is preferred along with knowledge of clinical trial methodology
  • BS/BSc/MS/MSc degree required
  • BA/BS 5+ years of relevant experience operational clinical trial experience
  • MBA/MS/ 3+ years of relevant experience operational clinical trial experience
  • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
  • Demonstrated clinical research experience and/or study management/startup project manager experience
  • Demonstrated experience in managing country level operational activities and/or vendors