Senior Project Manager - Clinical Quality Assurance QE/CAPA

Senior Project Manager - Clinical Quality Assurance QE/CAPA

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

The role is 100% embedded within a company that creates transformative medicines for people with serious diseases with a focus on specialty markets.

You will play a key role in making improvements to how teams perform their work, supporting positive gains on compliance and reducing procedural complexity within the Clinical Quality Assurance team.

• Lead cross-functional teams to drive investigation, root cause analysis (RCA) and CAPA development for Global Clinical Operations (GCO) Quality Events (QEs).
• Author investigation summary, RCA, Impact Assessments and CAPA utilizing Veeva QMS.
• Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management.
• Perform effectiveness checks, as assigned.
• Own and facilitate GCO planned deviations.
• Identifies and solves complex technical and operational problems, leveraging the appropriate resources.
• Liaise with Vertex clinical functions and external parties including CROs and Vendors to promote high level of quality and consistency across and within programs.
• Distribute notifications/ reminders for QE coming due and past due

You will have:

• Desired 7 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry.
• Strong end to end clinical trial execution experience.
• Strong verbal/written communication, presentation and interpersonal skills.
• Familiarity with Veeva QMS system
• In-depth understanding of GCP, ICH guidelines, CFR and ROW equivalents
• Excellent verbal and written communication skills and presentation skills: ability to interact well with various team members and provide value added support to project 
• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment 
• Experience managing clinical quality activities and in-depth knowledge of clinical operations. 
• Exhibits ability to multi-task effectively 

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/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.