Senior Project Manager - Clinical Quality Assurance

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.

What you will be doing:

Project Management & Execution

• Managing and drives all aspects of document development, revision, retirement, according to the team Charter, ensuring documents are written in alignment with procedures and quality standards.
• Ensuring Document Owner is informed of the process to develop, revise, or retire a controlled document.
• Supporting Document Owner with authoring. May author framework for new documents upon request and as appropriate.
• Managing and drives collaborative review, ensuring relevant functional area representation and drives resolution of edits/comments in collaboration with relevant stakeholders.
• Ensures completion of Learning Needs Assessment and Training Curriculum Impact Assessment.
• Supporting Head of Procedural Excellence with Implementation planning in close collaboration with Document Owner and other relevant stakeholders.
• Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS).
• Facilitates document revisions and VeeDMS workflows with guidance and oversight from the Head of Procedural Excellence, CAPA Lead, and/or Goals Lead.
• Performs non-GCO document reviews as delegated by Head of Procedural Excellence
• May act as a VeeQMS Action Item Owner for CAPA Action Items requiring a controlled document revision.

You are:

• Sponsor/CRO GCP experience required (~7-10+ years in a Clinical Project Manager or QA role is ideal)
• Very Strong English Language proficiency required (written and verbal)
• Strong operational understanding of Clinical Trials and GCP
• Very strong Project Management experience is a must - this person will be managing deliverables that depend on other people
• Exemplary organization, communication, and meeting facilitation skills - this is critical. This person needs to be able to clearly articulate concepts both verbally and in writing and facilitate meetings efficiently.
• Exemplary QC skills - this person needs to be detail oriented.
• Life Sciences degree

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.