Clinical Site Operations Manager

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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.

*What will you be doing?*

The *Site Operations Manager *is the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Relationship and Excellence Partner is the main point of contact and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and sponsor's reputation is that of "Partner of Choice."

The Site Operations Manager proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site communications and enhancing overall visibility into and confidence of quality of site-level activities.

* Responsible for relationship building and management

* Responsible for proactively providing local intelligence

* Accountable for study start-up, activation, and execution to plan

* Responsible for CRO and Study Management Interface

* Responsible for process, standards, and oversight

* Protocol Site Oversight

* Site and Study Management Interface

*Education: *

* Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.

*Skills: *

* 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management

* Read, write and speak fluent English; fluent in host country language required.* *

*Prior Experience*

* Solid knowledge of clinical development processes with strong emphasis on monitoring

* Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)

* Site Management/Monitoring (CRA) experience (preferred)

* Project management experience preferred in the clinical development area

* Ability to lead, troubleshoot and influence for delivery

* Independent approach

* Experience implementing centrally designed and developed initiatives on a local basis

*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.