Trial Manager - Early Development

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Job description

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.

As a Local Trial Manager, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.

We are seeking an experienced Local Trial Manager to work as an integral part of our pharma client's global study team. The key function of the Local Trial Manager is to provide operational country oversight and monitor progress of local activities of global studies by project managing a clinical team at a country level.

Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:

* To manage the local execution of study activities, leading the local trial team of on-site monitors (Site Managers) and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team

* To serve as the primary point of contact at a country level and report study progress to key stakeholders

* To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team

* To provide expert input into, or even independently create key study plans

* To develop and implement the use of local study tools (eg recruitment plans, risk management plans)

* To track the reporting of SAEs

* To maintain and update trial management systems (with the support of a Clinical Trial Assistant)

* To plan and participate in investigator meetings

* To review visit reports for completeness and adherence to the protocol and to identify site issues and trends

* To collaborate with other study team members as well as investigators and other site staff to build strong working relationships

A typical working day may include creating study documents, meeting with your team, sharing your expert local knowledge with other internal collaborates and even involvement with process improvement initiatives at a more global level. You will truly be a local study expert and will be expected to leverage your experience.

Organised, creative and confident in taking independent action.

To ensure success within this role, the following are required:

* A proven track record within study management

* An ability to combine creativity, leadership and experience to empower a team to succeed

* Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management

* Confidence in your decision-making abilities

* A working knowledge of a broad range of therapeutic areas

* A BA or BS degree in a health or science related discipline

* Fluency in English

*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.