Principal Manager, Clinical Quality Management

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Principal Manager, Clinical Quality Management (CQM) to join our diverse and dynamic team. As a Principal Manager, CQM you will be responsible for leading and managing projects, ensuring successful execution and delivery of project objectives.

What You Will Be Doing:

• 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.

• Supports internal and external audits and regulatory inspections by providing documentation, responding to auditor/inspector requests related to controlled documents, and ensuring timely resolution of audit findings or inspection observations related to the QMS.

Your Profile:

• 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

• It is essential that this person wants to use their knowledge and experience to improve the way Global Clinical Operations (GCO) runs clinical trials. This person will be leading meetings and facilitating conversations and completion of deliverables with Subject Matter Experts.

• 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 – this can be trained for the right person

• Exemplary organization, communication, and facilitation skills

• Exemplary QC skills

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   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.

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