Senior Central Monitor

Senior Central Monitor

Location: Home-based, HK

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.

This is a unique opportunity to join a global embedded sponsor team as a Senior Central Monitor (full-time) home-based anywhere in APAC.

This role forms an integral part of a growing Biotechnology company and plays a key role in the development of highly innovative cancer therapies with the support of ICON right behind you.

Key Responsibilities:

• Develop Risk-based Quality Management and Risk-Based Monitoring plans, ensuring accurate definition of key risk indicators and data quality assessment
• Apply advanced analytics to centrally aggregate and analyze data from disparate sources to identify risks and issues impacting data integrity, patient safety and/or regulatory compliance
• Mitigate risks by using signal detection and quality indicators
• Triage and assign findings identified to the appropriate project team role for follow-up and resolution
• Communicate trending analyses and a summary of findings to internal and external stakeholders to support the on-time delivery of data fit for analysis
• Ensure that all activities are in compliance with SOP, ICH-GCP, local and global laws, regulations and guidelines

Key Requirements:

• Must have a Bachelor of Science, Pharmacy, Medicine, Nursing or related healthcare field
• At least 12 months of working knowledge in a similar position and/ or previous experience as a clinical study lead with risked-based-monitoring experience
• Understanding of Clinical Data Management Systems and EDC
• Ability to interpret complex protocols and to identify risks and appropriate mitigation strategies for clinical studies.
• Basic ability in aggregate data review and interpretation using visualization/ analysis software e.g., JReview, Tableau, SAS.
• Strong communication skills
• Proactive approach and ability to work autonomously as well as part of a team

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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