Manager, Clinical Quality Compliance - US or Canada Remote

Overview

As a Manager, Clinical Quality Compliance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Point of contact for quality and compliance questions and work with QA to ensure alignment and consistent messaging to team based on GCP and regulatory requirements.
• Support team in identifying, escalating and putting risk plans in place to mitigate risks.
• Provide training to study teams, as needed
• Support teams in preparation for regulatory inspections of sponsor, country, site and vendor inspections
• Ensure adherence to GCP and overall quality as point of contact globally for sponsor study records.
• Support overall quality within on-going studies and submissions
• Work with teams to address quality issues with CROs and help teams bring them back in to compliance.
• Contribute and support facilitation, presentation and communication of lessons learned
• Derived proposals from Lessons Learn for process improvement
• Review critical/major findings with QA Audit reports to propose process improvement
• Support Teams in developing CAPA
• Collaborate with QA for information needed and requested for any global inspections
• Support teams in developing SOPs/WIs (global, regional, local)
• Review any SOPs/WIs development
• Support operational diagnostics to identify opportunities for improvement
• Provide input to Quality Plans
• Measure progress and targeting of results from improvement projects
• Develop matrix relationships to involve process experts and conduct improvement activities
• Ensure integration and alignment across organization
• Stay abreast of clinical trial requirements, FDA, EMA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.
• Become thoroughly familiar with assigned compounds and protocols.
• Facilitation and support of cross functional stakeholders

Qualifications

You are:

 

• Problem-solving and leadership to ensure continuous improvement
• Knowledge of relevant procedures
• High level of customer Service mindset
• Team Player/Ability to interact and collaborate with key stakeholders
• Experience in managing complex and sensitive operational challenges
• Adapt at identifying issues, driving to root cause and able to drive solutions
• Well-developed and effective verbal and written communication skills used in working with peers and employees at all levels of the organization
• Broad knowledge of Clinical Operations
• Acute attention to details

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree
• 5 years’ experience in a pharmaceutical, bio-pharmaceutical or Contract Research Organization company in a Quality role with a minimum of 5 years’ experience
• Understanding of Clinical Operations activities, with a preference for candidates with experience in this space
• Experience with sponsor/site audits in the region they oversee
• Experience in developing processes and/or SOPs and/or Wis
• Strong written and oral communication skills.
• Prior Regulatory inspection experience desired.
• Ability to travel

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.Our benefits examples include:

• 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belo