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Clinical Trial Manager

ICON Strategic Solutions

Canada

Remote

CAD 85,000 - 120,000

Full time

Yesterday
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Job summary

Join ICON Strategic Solutions as a Trial Manager. In this mid-senior level role, you will oversee clinical trial operations, ensuring adherence to regulatory standards while managing cross-functional teams and budgets. Your expertise in clinical trials and project management will contribute to our diverse and inclusive environment, promoting work-life balance and well-being for employees and their families.

Benefits

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning
Global Employee Assistance Programme
Flexible country-specific optional benefits

Qualifications

  • At least 3 years clinical trial experience for BA/BS or 2 years for advanced degree.
  • Must have strong knowledge of ICH/GCP guidelines.
  • Requires knowledge of clinical trial design and management.

Responsibilities

  • Manage day-to-day operations of assigned trials.
  • Lead cross-functional trial teams and ensure compliance with regulatory requirements.
  • Manage clinical trial budget and vendor contracts.

Skills

Project management skills
Interpersonal skills
Communication skills

Education

BA/BS degree or advanced degree (MS/PhD/PharmD)

Job description

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An opportunity to join a large global CRO in ICON as a Trial Manager for an exciting sponsor program!!

What you will be doing:

  • Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Leads or supports cross-functional trial teams, including vendors
  • Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
  • Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
  • Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
  • Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
  • Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
  • Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
  • Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
  • Provide oversight and direction to trial team members for trial deliverables
  • Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
  • Ensure quality and completeness of TMF for assigned clinical trials
  • Participates in inspection readiness activities including coordination of clinical trial team deliverables
  • Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
  • Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities

You are:

  • BA/BS degree with at least 3 years clinical trial experience.
  • Advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience
  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
  • Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
  • Requires project management skills and trial leadership ability
  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability

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.

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Research

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