Clinical Team Manager: Study Start Up

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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 Clinical Team Manager within Study Start Up, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

Working directly with investigative sites across the United Kingdom, the Manager of Study Start Up plays a fundamental role in our client's drug development process. The main focus will be working independently to Lead the study start-up activities at a country level.

*Main responsibilities:*

* Collaborating with the Project Manager to define the site activation strategy and develop timelines

* Manage submissions including the coordination of submissions packages, responding to EC queries

* Manage confidentiality agreements with sites

* Hold accountability for the exchange and tracking of study documents and translations, including quality checking, delegating some of these tasks to a CTA when appropriate

* Providing study updates to the wider project team

* Proactively identify and resolve any site challenges, and implement mitigation plans to any risks to study start-up, identifying trends and triaging issues as needed

* Build productive working relationships with investigative sites

Interfacing with other key stakeholders in the business including the medical team and project management, the Manager of Study Start Up's expertise will be called upon to work independently, taking ownership for study start-up and adopting an autonomous approach to decision-making.

*You are:*

Organised, confident and quick to learn.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

* A proven track record of success in study start-up activities in either a CRO or pharmaceutical company, including submissions, managing timelines and driving delivery

* The ability to identify risk and make decisions

* Fluency in English and Polish

* The ability to communicate confidently and learn quickly are also key attributes.

*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.