Manager, Clinical Quality Compliance - US or Canada Remote Posted Date 1 week ago(12/13/2024 6:05 PM) ID 2024-115323 Location : Location US-Remote Location : Location CA-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 neededSupport teams in preparation for regulatory inspections of sponsor, country, site and vendor inspectionsEnsure adherence to GCP and overall quality as point of contact globally for sponsor study records.Support overall quality within on-going studies and submissionsWork 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 learnedDerived proposals from Lessons Learn for process improvementReview critical/major findings with QA Audit reports to propose process improvementSupport Teams in developing CAPACollaborate with QA for information needed and requested for any global inspectionsSupport teams in developing SOPs/WIs (global, regional, local)Review any SOPs/WIs developmentSupport operational diagnostics to identify opportunities for improvementProvide input to Quality PlansMeasure progress and targeting of results from improvement projectsDevelop matrix relationships to involve process experts and conduct improvement activitiesEnsure integration and alignment across organizationStay 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 improvementKnowledge of relevant proceduresHigh level of customer Service mindsetTeam Player/Ability to interact and collaborate with key stakeholdersExperience in managing complex and sensitive operational challengesAdapt at identifying issues, driving to root cause and able to drive solutionsWell-developed and effective verbal and written communication skills used in working with peers and employees at all levels of the organizationBroad knowledge of Clinical OperationsAcute attention to details

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

Bachelor’s degree5 years’ experience in a pharmaceutical, bio-pharmaceutical or Contract Research Organization company in a Quality role with a minimum of 5 years’ experienceUnderstanding of Clinical Operations activities, with a preference for candidates with experience in this spaceExperience with sponsor/site audits in the region they overseeExperience in developing processes and/or SOPs and/or WisStrong 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 entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal 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-beingLife assuranceFlexible 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/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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