Clinical Risk Manager

We are looking for a Clinical Risk Manager to join our Risk Based Quality Management team as people leader and line manager for RBQM.

Candidates should have strong knowledge of Risk Based Quality Management, Risk Based Monitoring, and Central Monitoring requirements in the Pharma or CRO industry. Line Management experience preferred.

We are looking for someone with excellent people leader, coaching skills and critical thinking skills, to support team governance, development and growth.

Role can be based in US or EU

Main job functions/responsibilities will be as follows:

• Recognize, exemplify and adhere to ICON's values, which center on Accountability & Delivery, Collaboration, Partnership and Integrity.
• Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Executes the responsibilities of disciplined adoption and robust implementation of ICON's Risk Based Quality Management across ICON and with customers, communicating with clarity.
• Deliver and maintain client-focused reporting to measure performance and proactively identify issues.
• Drives and implements change management, process review & design as well as development of effective training.
• Prepare, design and present or support at proposals, bid defences, KOMs, Sponsor Audits.
• Contributes to the development and implementation of the services of the Clinical Efficiency, Quality and Prevention in support of PMOG and Project Management, establishing standards and maintaining systems to measure quality/risk in performance against the established standards.
• Plans and Manages disciplined and robust implementation of Clinical Risk Management, supporting Risk assessments; monitors effectiveness of Risk Identification, Risk Mitigation and Risk Prevention approaches.
• Conducts Quality Control activities to identify Risks.
• Makes independent decisions that have impact on the services and clinical trials regarding the Risk Based Quality Monitoring strategy.
• Provide lessons learned and expertise, as relevant.
• Liaise and co-operate with IT, Clinical Data Services, Quality Assurance in determining strategies and technologies to address Risk and Opportunities for the development of new business.
• Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for monitoring activities
• Establish and maintain necessary communication strategy for the improvement and awareness of quality issues across all departments.
• Act as Enterprise level lead and provide expert RBQM and RBM knowledge for agreed key client partnership accounts.
• Makes sound decisions based on available information in order to contribute to the success of ICON.
• Delivers with high quality standards and strives for excellence; acts in a proactive, flexible and responsive manner to customer needs.
• Establishes good relationships internally and externally.
• Maintains awareness of evolutions in technology, sponsor and competitor positions as well as regulations affecting Risk Based Monitoring.
• Travel (approximately 30%) domestic and/or international.

What you need:

• University/Bachelor's Degree in medicine, science or equivalent degree/experience.
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring.
• 8+ years experience in Clinical Research with 4+ years experience in central monitoring and line management, or relevant skillset.
• Fluent in written and spoken English
• Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license and passport.