Overview

Clinical Risk Manager / Clinical Trial Manager role at ICON Strategic Solutions. UK-homebased. The successful candidate will start in September or October. The role is within a global study team, focusing on risk management in clinical research.

Responsibilities

• Lead the successful implementation and ongoing execution of Risk Management for assigned global clinical studies, across early and late phase and observational clinical research
• Lead the Clinical Study Team to drive effective decision making for risk management
• Ensure risk management implementation and conduct of studies 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 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 focused approach
• Able to use operational expertise to quickly adapt to new challenges, 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

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 studies 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

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. Our patients are at the centre of all that we do, and we help accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength and are at the core of our culture. We are committed to developing our employees in a continuous learning culture. ICON focuses on providing a comprehensive and competitive total reward package, including base pay, a range of variable pay and recognition programs, and best-in-class benefits and wellbeing initiatives. ICON is committed to an inclusive and accessible environment for all candidates, with equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you need a reasonable accommodation during the application process or to perform essential functions of a position, please let us know.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Health Care Provider
• Industries
• Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at ICON Strategic Solutions by 2x

Sign in to set job alerts for “Clinical Risk Manager” roles.