Clinical Quality Management (CQM), Principal Manager - Home-Based
Company: ICON Strategic Solutions
Location: Denver
Posted on: May 28, 2023
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Job Description:
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.
Keywords: ICON Strategic Solutions, Denver , Clinical Quality Management (CQM), Principal Manager - Home-Based, Executive , Denver, Colorado
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