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Clinical Site Liaison

2 mesi fa


Lazio, Italia Icon Strategic Solutions A tempo pieno

As a Clinical Site Liaison, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The Clinical Site Liaison is a field-based expert who supports the conduct and the patient recruitment of the client global clinical trials at investigative sites, through local and relational support.
What you will be doing: Participate in study-level feasibility activities through providing key country/ regional and site specific knowledge including patient pathways and operational execution.
Interface and act as a local client TrialOps representative, an expert on the clinical trial protocol(s) and SME providing the sites with knowledge and awareness about the current and upcoming clinical trials.
Lead and engage in local site, KOL and network engagement initiatives in view of the clinical trials.
Contribute to the trial specific site feasibility / selection strategy and collaborate with the Clinical Trial Team (CTT) and CRO to support the site start-up process as needed.
Facilitate with the site contract negotiation/signature as needed.
Proactively work to fully understand all matters that impact the successful patient recruitment and high quality conduct of the clinical trial at each site, eg the Principle Investigator (PI) and site preferences and best practices on clinical trials, standard of care treatments, competing studies etc.
Ensure a supportive relationship with clinical sites and trial personnel.
Proactively work to fully understand the patient voice, preferences and pathway(s).
Closely work with the client GPA team.
Speak to patient groups and support groups, live events and conferences as allowed by local / regional guidance.
May also attend live and virtual patient events to assist in responding to questions about client, the trial(s) and other information.
May participate in monitoring oversight activities such as accompanying the CRO CRA during site visits.
This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements.
Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support.
Optimize site engagement for a specific trial to ensure site engagement and quality for the site-level enrollment and execution of every trial.
Oversee and track patient recruitment for the regional sites and pro-actively identify ways to prevent recruitment delays Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the respective study CTM, CODL, Global Head of Clinical Site Communication, Recruitment and Liaisons, Head of Trial Operations and/or Senior Management, as needed Identify efficiencies, best practices and lessons learnt and ensure they are shared across trials/indications/compounds Search for and embrace innovation May be asked to provide input to the clinical development strategy/plan Participate in workstreams and provide input to procedures/SOPs/WIs and related documents You are: Bachelor's degree, Scientific or health related field University degree - medical or para-medical (MD, Biology, Biomedical Sciences, Pharmacy, Veterinary etc.)
or equivalent by experience Minimum of 6 years of experience in Biotech / pharma preferably in roles including site engagement and / or clinical trial monitoring experience Ability for travel nationally and occasional international travel.
Experience in global clinical trials is a plus Prior experience in Neurology, Auto-immune and rare disease background Knowledge of ICH-GCP and other applicable legislation Ability to quickly understand complex neurological disease areas, treatments and clinical development plans Understand the healthcare therapeutic landscape, patient pathways and investigative sites Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, networks, PAGs, CROs and others Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority Highly developed organizational skills, problem solving, analytic and able to prioritize Experience with tools and systems for managing clinical studies What ICON can offer you: Our success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Diversity and Inclusion: At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
We're dedicated to providing an inclusive and accessible environment for all candidates.
ICON 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.
Application Encouragement: 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.
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