Clinical Trial Manager (US or Canada Remote)

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.

Responsibilities

• Act as Global or Regional Protocol Lead. Serve as main point of contact for clinical site management.

• May act as mentor for less senior RCTO staff on the study.
• Participate as the main point of contact for RCTO on the Clinical Study Team.
• Supports Molecule Lead. Closely collaborates with internal study team members, Contract Research Organizations, vendors or sites.
• Monitors metrics to drive on-time delivery of clinical trial milestones.
• Assist with creation and review of protocols/ICFs and clinical trial documents.
• Lead in identification, evaluation, and selection of clinical trial sites.
• Coordinate and manage vendor processes. May contribute to vendor selection.

• Facilitate communication between sites and cross-functional staff.
• Lead functional teams within RCTO.
• Conduct data review.
• Accountable for completeness of Trial Master File.
• Support audit and/or inspection activities
• Primary point of contact for CRO activities.
• May lead process improvement initiatives and departmental projects.
• Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.

Qualifications

• BA/BS or equivalent or any relevant and qualifying training with a minimum of 8 years of relevant clinical trial management experience.
• Ability and willingness to travel
• Global Phase I-III trial Management experience.
• CRO management experience.
• Thorough knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive.
• Experience managing large teams (direct or dotted line reporting)
• Excellent leadership, communication, and organizational skills.
• Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
• Strong communication and inter-personal skills.
• Highly responsive and proactive, a team player
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)

Benefits of Working in ICON:

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, color, 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.