Clinical Risk Manager

UK homebased Clinical Trial Manager performing Clinical Risk Manager (CRM) duties

Are you an experienced Clinical Research or Clinical Project Manager with a flair for innovation, team leadership and engagement and a proactive approach to managing risk in clinical research?  

Are you looking for your next challenge in a novel and specialised role in which you can utilise your extensive clinical research expertise, working with multiple stakeholders to influence the design and conduct of global clinical trials, incorporating the evaluation of risk and mitigation throughout?

Working for Icon, with a mission to help clients accelerate the development of drugs and devices that save lives and improve quality of life and on placement within a single client, we are looking for candidates who are ready to take a leading role in a new team of Clinical Risk Managers to develop the role and the wider Risk Management initiative, within our client’s organisation.

Key Purpose

• Lead the successful implementation and ongoing execution of Risk Management for assigned, global clinical studies, across early and late phase and observational clinical research

Key Activities

• Leading the Clinical Study Team to drive effective decision making for risk management
• Ensuring risk management implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Accountable for CT-RACT completion and updates (performed by the Clinical Study Team) throughout the lifecycle of the clinical study
• Input to the development of the study protocol and functional plans
• Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes
• Support the development of risk mitigation strategies and lead reviews of mitigation effectiveness.
• Analyse, summarize and report findings to inform future study design and library of mitigations.

Key Competencies

• Cross functional awareness/organisationally savvy
• Ability to work effectively in a matrix environment with multiple stakeholders on multiple projects
• Relationship management
• Oral and written communication
• Time management
• Business English
• Negotiation and influencing skills
• Critical thinking and analytical skills
• Ability to prioritise effectively and adapt to competing demands
• Proactive creative thinker

Key requirements

• Significant clinical trial management and leadership skills are essential, ideally gained within the pharma, biotech or CRO environment and preferably including regional or global experience
• The ability to influence change through a collaborative style with excellent communication skills and a team focussed approach
• Able to use operational expertise to quickly adapt to new challenges, coupled with the ability to see the ‘big picture’, engaging multiple stakeholders at all levels of the organisation, to proactively identify, evaluate and mitigate risks in clinical research design, conduct and delivery.

What is required

• BS/BA/BSc in the sciences or RN
• Ideally, 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
• Experience of oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
• Advanced knowledge of global clinical trial management
• Experience as Risk manager preferred
• Knowledge of (ICH-GCP), and applicable international regulations and guidelines, including risk management principles for clinical trials

What is offered

• Full-time and permanent contract of employment with us seconded to a single sponsor company
• The role is NOT open to Freelancers/Freelance Contractors
• The role is homebased in the UK/England
• Salary according to level of skills and experience
• Company benefits and annual leave

Why Join?

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.

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, 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.

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