GCP QA Sr Project Manager

ICON; New York (NY); Remote; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a Senior Project Manager to enhance team performance within Clinical Quality Assurance. This role involves managing document development and revisions, ensuring compliance with quality standards, and facilitating collaborative reviews. With a focus on improving procedural efficiency, you will leverage your extensive project management experience and strong understanding of clinical trials. The company values diverse talent and offers a competitive salary alongside various benefits that promote well-being and work-life balance. If you're passionate about making a difference in clinical research, this opportunity is for you.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Gym discounts

Travel passes

Health assessments

Qualifications

• Extensive Project Management experience, managing interdependent deliverables.
• Strong operational understanding of Clinical Trials and GCP.

Responsibilities

• Manage and drive all aspects of document development, revision, and retirement.
• Coordinate final endorsement of documents prior to approval workflows.

Skills

Project Management

Clinical Trials Knowledge

GCP (Good Clinical Practice)

Communication Skills

Detail-oriented

Facilitation Skills

Education

Life Sciences Degree

Tools

VeeDMS

VeeQMS

Job description

Senior Project Manager - Clinical Quality Assurance (Homebased in the UK)

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

The role is fully embedded within a company that creates transformative medicines for people with serious diseases, focusing on specialty markets.

You will play a key role in improving team performance, supporting positive gains in compliance, and reducing procedural complexity within the Clinical Quality Assurance team.

What you will be doing:

Project Management & Execution

• Manage and drive all aspects of document development, revision, and retirement according to the team Charter, ensuring alignment with procedures and quality standards.
• Ensure Document Owners are informed of the processes to develop, revise, or retire controlled documents.
• Support Document Owners with authoring; may author frameworks for new documents as appropriate.
• Manage and facilitate collaborative reviews, ensuring relevant functional area representation, and drive resolution of edits/comments with stakeholders.
• Ensure completion of Learning Needs Assessments and Training Curriculum Impact Assessments.
• Support the Head of Procedural Excellence with implementation planning in collaboration with Document Owners and stakeholders.
• Coordinate final endorsement of documents prior to approval workflows in the Document Management System (DMS).
• Facilitate document revisions and workflows within VeeDMS under guidance from the Head of Procedural Excellence, CAPA Lead, or Goals Lead.
• Perform non-GCO document reviews as delegated by the Head of Procedural Excellence.
• May act as a VeeQMS Action Item Owner for CAPA actions requiring document revisions.

You are:

• Proficient in English (written and verbal).
• Strong operational understanding of Clinical Trials and GCP.
• Extensive Project Management experience, managing interdependent deliverables.
• Excellent organization, communication, and facilitation skills; able to articulate concepts clearly and facilitate meetings efficiently.
• Detail-oriented with strong QC skills.
• Holding a Life Sciences degree.

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What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme through TELUS Health
• Life assurance
• Country-specific benefits like childcare vouchers, gym discounts, travel passes, and health assessments

Visit our careers website for more: https://careers.iconplc.com/benefits and https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply—perhaps you are exactly who we are looking for, regardless of whether you meet every criterion.