Job Description

Overview

As a Site Engagement Liaison you will be joining the worldxe2x80x99s largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.

Responsibilities

Responsibilities

The Site Engagement Liaison 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.

Responsible for relationship building and management:

• Usher investigator sites through site activation and study activities from study start up to close out.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Lead effective site recruitment planning and implementation of plans at the country and site-level, consistent with global plan and local targets.

Responsible for proactively providing local intelligence:

• Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
• Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
• Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.

Accountable for study start-up, activation, and execution to plan for targeted sites:

• Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating client functions to standardize processes and deliver activation in line with the targeted site strategy.
• Confirm (and educate where needed) that sites are familiar with client requirements for study start up and facilitate the availability of MSAs when feasible.
• Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
• Conduct SIVs if required

Responsible for process, standards, and oversight:

• Responsible for site and monitoring quality, regulatory and GCP compliance.
• Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks.
• Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
• Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.).
• Demonstrate use of data to enhance quality and accelerate study delivery.

Accountable for study start-up, activation, and execution to plan for targeted sites:

• Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating client functions to standardize processes and deliver activation in line with the targeted site strategy.
• Confirm (and educate where needed) that sites are familiar with client requirements for study start up and facilitate the availability of MSAs when feasible.
• Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
• Conduct SIVs if required

Responsible for process, standards, and oversight:

• Responsible for site and monitoring quality, regulatory and GCP compliance.
• Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
• Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.).
• Demonstrate use of data to enhance quality and accelerate study delivery.

Qualifications

Qualifications

A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:

• BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
• Skills in more than one language are an advantage in this role. English is required
• 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

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. Thatxe2x80x99s why we are committed to developing our employees in a continuous learning culture xe2x80x93 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 xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.

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