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Senior SMA

  1. Warsaw
JR120949
  1. Clinical Trial Support
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

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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 and biotechnology organisations.

With our patients at the center 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.

Our ICON Biotech Department offers our Site Management Associate’s in (add country) a supportive and collaborative environment and the opportunity  to gain a wide range of therapeutic experience with a focus on offering a flexible and adaptable mindset and approach to make our client’s needs.

Our ICON Biotech Department is world class and offers huge opportunities for career growth and development through our internal training programs and promotion pathways, ongoing mentoring and employee reward and recognition.

Key responsibilities :

As a Site Management Associate, you will be the first point of contact for site staff and you will work closely with the study sites to provide remote support and to ensure patient safety and data integrity.

You will work closely with CRAs to ensure they are up to date with the current status of the sites to maximise the impact of monitoring visits they performed and play a central and key role between Start Up staff, CRA, Site and Central reviewers.

Site Management Associates are critical to monitoring the clinical risk on their studies and their goals include:

  • Reduce the time it takes to bring new medicines to patients
  • Improve the quality of the data collected on clinical trials
  • Ensure the study is run in compliance with GCP and that the safety and rights of the study participants are protected
  • Maintain the Trial Master File
  • Ensure appropriate documentation in place to meet Regulatory Requirements
  • You may also perform Site Management Contacts (SMC) or off site Pre Site Selection visits. Follow up with site staff to address the findings from central analytics review .

You will be operating as a key part of a global study team and plays a fundamental role in our clients’ drug development processes.

The Requirements

To enable success in this position you will need :

  • Prior experience of working in investigator site management, from either a pharmaceutical company or a CRO environment.
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
  • You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
  • Fluent in English

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

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