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

Role Details

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.

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.

• 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

Benefits of Working in ICON:

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.

At 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.

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, 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.

ICON Strategic Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.