Clinical Quality Manager (CQM), Principal Manager - Home-Based

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

Clinical Quality Management (CQM) Procedural Excellence is a team of staff responsible for stewardship (i.e., governance, control, and management) of controlled and non-controlled documents owned by departments within Global Clinical Operations (GCO). The objective of CQM Procedural Excellence is to ensure compliant, consistent, scalable, and efficient procedures by providing process expertise, aligning cross-functionally with relevant subject matter experts and department leadership across GCO and GMDA.

What you will be doing:

Project Management & Execution

• Manages and drives all aspects of document development, revision, retirement, according to the Procedure section of this Charter, ensuring documents are written in alignment with sponsor procedures and quality standards.
• Ensures Document Owner is informed of the process to develop, revise, or retire a controlled document.
• Supports Document Owner with authoring. May author new documents upon request and as appropriate.
• Manages 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.
• Leads and drives 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).
• Acts as QMS Action Item Owner for CAPA Action Items requiring a controlled document revision.
• Acts as QMS Planned Deviation Owner for Planned Deviations identified as part of implementation planning.

You are:

• Bachelor’s degree in a life sciences discipline highly preferred
• Typically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry
• Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)
• Strong operational understanding of Clinical Trials and GCP
• Project Management experience is a must
• Strong interest and understanding of Process/Controlled Document Management 
• Exemplary organization, communication, and facilitation skills
• Exemplary QC skills

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.

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