Study Manager IVD(R)

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.

We are seekign one Study MAnager to spearhead our clinets studies in the Eu.

Responsible for the successful planning, implementation and conduct of clinical studies to verify and validate clinical software, instrument platforms, assays and biomarkers developed by RMS. Functionally responsible for all clinical study preparation and conduct activities throughout the duration of each assigned clinical trial. Assures clear external/inter nal team communication, process documentation, and compliance with Roche and departmental processes along with Good Clinical Practices and procedures set forth.

Main responsibiliti es: – Support in IVDR submission according to new regulations – Study Management of EU studies

To Be Successful in The Role You Will Have

To Be Successful In This Role You Will Have
7 years of experience in clinical trials
ideally experience in study management in EU
ideally experience with path labs
Experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs
Working knowledge of global and local regulatory requirements is nice to have
Understand the quality expectations and emphasis on the right first time, attention to detail
Ability to organize tasks, time, and priorities, ability to multi-task
Required to support multi-national team members, and flexibility in working hours may be needed.
Participate and work effectively with multiple cross-functional teams

What is Offered
Work for one of the global top two CROs, sponsor dedicated in one of the global top pharmaceutical companies fully integrated and from the sponsor’s perspective
Permanent contract (full time)
Homeoffice 100%, no travel required
Thorough onboarding training under mentorship
Excellent career options

Sounds like a good fit? Get in touch with me today!

Please submit your CV to [email protected] or via our homepage www.ICONplc.com/FSP. We are looking forward to your application.

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.