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Manager, Clinical Quality Compliance

2 months ago

Remote, Canada ICON Clinical Research Full time

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

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

You are:

Skills/qualification

  • 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
  • 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

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, 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.

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.