Country Study Operations Manager I (C-SOM)

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.

The Country Study Operations Manager will have responsibilities for regional or specific country level activities from study startup through conduct and study close. The Country Study Operations Manager has responsibility for study management aspects of assigned studies. The Study Operations Manager will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, Study Operational Managers and the larger Study Management delivery of the study.

What you will be doing:

• Regional/Country level implementation of Startup and Site Activation Plans (through SUPM
  or pCRO if assigned)
• Leading the Country Operational sub team: primary team members (Site Care Partners) and Ad hoc members (Site Activation Partners, monitors, contracts, Local Regulatory, Medical affairs, Legal, etc)
• Regional/Country level Recruitment Strategy
• Responsible to support the development of study plans
• Communication with the local team and internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
• Responsible for country vendor management and oversight including follow up and coordination of vendor deliverables
• Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
• The Country Study Operational Manager will be able to work independently and exercise their own judgement.

You are:

Training and Education

• Relevant operational clinical trial experience
• A scientific or technical degree is preferred along with knowledge of clinical trial methodology
• BA/BS 5+ years of relevant experience
• MBA/MS/ 3+ years of relevant experience
• BS/BSc/MS/MSc
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• Italian and English is required

Prior Experience

• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Experience in Study and Quality management and working in a matrix management environment

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.