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

Working fully embedded within one of our pharmaceutical clients, with the support of ICON right behind you, you'll be at the heart of our client's innovation. As Study Start-up Lead, you will be dedicated to one of our global pharmaceutical clients; a fast-growing biotech company with one of the most exciting product pipelines in the industry. This global client develops breakthrough innovative medicines to improve and extend people's lives with targeted therapies for cancer. Join the fight against cancer at this sponsor who is running more than 60 clinical trials globally in the area of solid tumors and hematologic cancers. Position Overview:Our Study Start Up structure represents an integrated, dedicated, seamless team of experts, all striving to minimize cycle times. This is especially true of our dedicated and passionate Study Start Up Leads.As a Start Up Lead, you will lead all aspects of Start Up activities at local level to achieve quick and successful activation of sites, overseeing and driving all aspects of study start up for your country You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals. Responsibilities

• Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.
• Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs.
• Adopting our unique start-up methodology to drive early and predictable site activations through oversight of all activities, driving delivery and compliance across the assigned region.
• Coordinate study start up activities
• Perform independent quality review of submission packages.
• Working collaboratively with functional colleagues and sponsors to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Contracts and Clinical Team Management.
• Ensuring understanding and communication within the country
• Eliminating all potential causes of delay.
• Overseeing compliance and reporting progress.

Fully supported by your functional management, whilst also benefitting from department training, best practice calls and participation in working groups, you will play a fundamental role in bringing treatments to market.
Qualifications

You are: An experienced, ambitious self-starter looking for the opportunity to prove yourself in an embedded role at a top three pharmaceutical company. 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 life-sciences undergraduate degree (or be a licensed healthcare professional)
• Solid experience in managing Study Start Up activities across the country, managing and meeting deliverables
• A passion for Study Start Up which drives you to motivate yourself and others
• Previous experience of working in a CRO environment
• An attitude that fosters collaboration and a sense of shared focus within a team

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.