Clinical Risk Manager

Role can be based in the EU or USA

Job Description

We are looking for a Clinical Risk Manager to join our Central Monitoring team as people leader and support to central monitoring implementation at ICON.

Candidates should have strong knowledge of risk-based monitoring/central monitoring requirements, and experience with central monitoring and line management in the Pharma or CRO industry.

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

The role
As a Clinical Risk Manager you will act as people leader in the ICON Central Monitoring team, by managing Clinical Data Analysts and Central Monitors, prioritizing, driving and overseeing the set-up and implementation of central monitoring on projects. You will oversee project activity and ensure central monitoring set-up and output delivery via a governance process. You will drive people growth, ownership, performance culture and critical thinking via coaching and technical oversight.

As part of the Central Monitoring line management team, you will propose, support and own initiatives about team organization and process improvements. With strong financial and business awareness, you will support revenue and budget evaluation, via accurate tracking and projection of central monitoring activities and resource needs.

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.
• Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Line management of Clinical Data Analysts/Central Monitors/Analytics Development Leads (selection and recruitment, goal setting, performance reviews, project assignments, workload management, governance, succession planning).
• Conduct QC of risk indicator and clinical data analysis output.
• Support and coach the Clinical Data Analysts in their functional lead role.
• Facilitate the adoption and understanding of central monitoring across project teams.
• Lead/support working groups in initiatives for risk-based quality management and central monitoring or related process/system improvement.
• 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 central monitoring activities.
• Support Business Development with central monitoring strategy and budgeting, support or attend bid defense meetings.
• Support budget evaluation, revenue recognition process and financial objectives for the department.
• Support the CRM group strategy as set by CRM Leadership including input into development planning for ICONik and other CRM tool adoption and enhancements
• Travel (approximately 5%) 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.
• Financial and business awareness.
• 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.