Global Clinical Trial Manager

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.

The Global Clinical Trial Manager supports operational and some scientific aspects of global clinical trial(s), assisting day-to-day requirements of the clinical trial.

1. The Global Clinical Trial Manager ensures all trial deliverables are met according to timelines, budget, operational procedures, quality /compliance and performance standards.

Assigned responsibilities can include but are not limited to :

• Development of specific sections of the protocol and related documents;
• Development of study tools, guidelines and training materials;
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
• Supporting the development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); supporting managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards in their work for the trial; contributing to the development/amendment of vendor contracts;
• Implementing issue resolution plans;
• Supporting management of interactions with relevant line functions including data management, drug supply management, clinical development and local affiliates;
• Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.

2. Member of the global cross-functional Clinical Trial Team; participates and reports study progress and issues/resolution plan.

3. Supports data flow.

4. Responsible for implementation of and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s).

• Bachelor degree or equivalent degree is required, with advanced degree preferred. At least one of the degrees in life
  science/healthcare is preferred.
• If Registered Nurse (with <3 years nursing education) or no science degree/equivalent degree, must have at least 3 years of clinical development experience.
• Prior experience in a Clinical Trial Management role.
• Fluent English (oral and written).
• Good communication, organization and tracking skills.
• Knowledge of Good Clinical Practice; knowledge of clinical trial design; knowledge of scientific principles.

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.