Clinical Quality Project Manager

Job not on LinkedIn

November 13

Apply Now

Receive Emails with Similar Jobs

ICON plc

WebsiteLinkedInAll Job Openings

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize 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.